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OP RSH PRO00041362 EFSTATHIOU 78278343PCR3001 TREATMENT ARM 1	

Types:      Research Oncology Treatment
Synonyms:  PRO00041362 EFSTATHIOU, 78278343PCR3001

Cycle 1	Repeat 1 time	Cycle length: 56 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	Verify Hep B panel status prior to cycle. Date *** of panel. Result positive/negative/pending/unknown:22867

The required components for the hepatitis B panel includes: Hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (anti-HBc), and hepatitis B antibody (anti-HBs).
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 5MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 3.5 mg in dextrose 5% 50 mL infusion	Dose: 3.5 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Infuse IV over 60 minutes. Do not use a filter to administer the 3.5mg dose level.  Primed with D5W. Flush only with D5W.  Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 18MG INTRAVENOUS SOLN (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	3.5 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	49.3 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 5MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 18 mg in dextrose 5% 50 mL infusion	Dose: 18 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 60 Minutes	Instructions:	Infuse IV over 60 minutes through a 0.2 micron inline filter.  Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 18MG INTRAVENOUS SOLN (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	18 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	46.4 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Post Dose.PK samples collected at the EOI (post dose): (0-30 mins after) should be drawn from the contralateral arm where pasritamig was infused and after IV line is flushed.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 50MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 300 mg in dextrose 5% 100 mL infusion	Dose: 300 mg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Infuse initial dose at 300mg over 60 minutes, and subsequent doses over 30 minutes if tolerated.  Administer through a 0.2 micron inline filter.  Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 300MG (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	300 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	94 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 36	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
					
Cycle 2	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Imaging
☑	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT scan. 
If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria. Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		☑	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Imaging
◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Optional: Fresh biopsy of a metastatic lesion can be collected at any time point while the participant is on treatment starting at C2D1 and/or EOT from participants at select investigational sites. Collect as clinically feasible
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 50MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 300 mg in dextrose 5% 100 mL infusion	Dose: 300 mg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Infuse over 30 minutes if tolerated. Administer through a 0.2 micron inline filter. Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 300MG (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	300 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	94 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
					
Cycle 3	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Imaging
☑	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT scan. 
If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria. Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		☑	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Imaging
◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Post Dose.PK samples collected at the EOI (post dose): (0-30 mins after) should be drawn from the contralateral arm where pasritamig was infused and after IV line is flushed.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Optional: Fresh biopsy of a metastatic lesion can be collected at any time point while the participant is on treatment starting at C2D1 and/or EOT from participants at select investigational sites. Collect as clinically feasible
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 50MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 300 mg in dextrose 5% 100 mL infusion	Dose: 300 mg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Infuse over 30 minutes if tolerated. Administer through a 0.2 micron inline filter. Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 300MG (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	300 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	94 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
					
Cycle 4	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Imaging
☑	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT scan. 
If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria. Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		☑	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Imaging
◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Optional: Fresh biopsy of a metastatic lesion can be collected at any time point while the participant is on treatment starting at C2D1 and/or EOT from participants at select investigational sites. Collect as clinically feasible
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 50MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 300 mg in dextrose 5% 100 mL infusion	Dose: 300 mg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Infuse over 30 minutes if tolerated. Administer through a 0.2 micron inline filter. Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 300MG (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	300 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	94 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
					
Cycle 5	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 50MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 300 mg in dextrose 5% 100 mL infusion	Dose: 300 mg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Infuse over 30 minutes if tolerated. Administer through a 0.2 micron inline filter. Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 300MG (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	300 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	94 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

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			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
					
Cycle 6	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Imaging
☑	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT scan. 
If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria. Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		☑	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Imaging
◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required. C10D1, C14D1, C18D1, C22D1, C26D1 (every subsequent 4 cycles)
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	C6D1, C10D1, C14D1, C18D1, C22D1, C26D1 (every subsequent 4 cycles)
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Optional: Fresh biopsy of a metastatic lesion can be collected at any time point while the participant is on treatment starting at C2D1 and/or EOT from participants at select investigational sites. Collect as clinically feasible
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.C6D1, C10D1. C14D1, C18D1, C22D1, C26D1 (every subsequent 4 cycles)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 50MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 300 mg in dextrose 5% 100 mL infusion	Dose: 300 mg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Infuse over 30 minutes if tolerated. Administer through a 0.2 micron inline filter. Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 300MG (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	300 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	94 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
					
Cycle 7	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 50MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 300 mg in dextrose 5% 100 mL infusion	Dose: 300 mg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Infuse over 30 minutes if tolerated. Administer through a 0.2 micron inline filter. Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 300MG (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	300 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	94 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
					
Cycle 8	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments:C11D1 then every 3 cycles
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required. C8D1, C10D1, C14D1, C18D1, C22D1, C26D1 (every subsequent 4 cycles),
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Optional: Fresh biopsy of a metastatic lesion can be collected at any time point while the participant is on treatment starting at C2D1 and/or EOT from participants at select investigational sites. Collect as clinically feasible.C8D1, C10D1, and Every subsequent 4 cycles (Cycle 14, 18, etc)
			Imaging
☑	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT scan. 
If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria. Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		☑	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Imaging
◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 50MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 300 mg in dextrose 5% 100 mL infusion	Dose: 300 mg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Infuse over 30 minutes if tolerated. Administer through a 0.2 micron inline filter. Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 300MG (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	300 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	94 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 22	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
					
Subsequent Cycles (every 6 Weeks)	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments:C11D1 then every 3 cycles
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Nursing communication
-         Post-dose vital signs assessments should be performed every hour (Greater than or EQUAL to 30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). 
Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required. C10D1, C14D1, C18D1, C22D1, C26D1 (every subsequent 4 cycles)
			Imaging
☑	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT scan. 
If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria. Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		☑	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Imaging
◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	If the treatment is delayed, scans should still take place at appropriate time window. Scans are collected only until radiographic progression per PCWG3 and RECIST v1.1 criteria.Week 8, Week 14, Week 20, Week 32, Week 44, Week 56, then Q12W thereafter
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	C6D1, C10D1, C14D1, C18D1, C22D1, C26D1 (every subsequent 4 cycles)
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required. C8D1, C10D1, C14D1, C18D1, C22D1, C26D1 (every subsequent 4 cycles),
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.C6D1, C10D1. C14D1, C18D1, C22D1, C26D1 (every subsequent 4 cycles)
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Optional: Fresh biopsy of a metastatic lesion can be collected at any time point while the participant is on treatment starting at C2D1 and/or EOT from participants at select investigational sites. Collect as clinically feasible.C8D1, C10D1, and Every subsequent 4 cycles (Cycle 14, 18, etc)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Pre-Medications
☑	dexAMETHasone (DECADRON) 16 mg in sodium chloride 0.9% IVPB	Dose: 16 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DEXAMETHASONE SODIUM PHOSPHATE 4 MG/ML INJECTION SOLUTION	Medications	16 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose				Instructions:	Must be administered within 2 hours prior to study treatment 		☑	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Must be administered within 2 hours prior to study treatment 			Chemotherapy
  	INV-PASRITAMIG/PLACEBO 50MG/ML (78278343PCR3001/PRO00041362/EFSTATHIOU) 300 mg in dextrose 5% 100 mL infusion	Dose: 300 mg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Infuse over 30 minutes if tolerated. Administer through a 0.2 micron inline filter. Primed with D5W.  Flush only with D5W. Stable 4 hours at room temp from first vial puncture until the end of the infusion (24 hours refrigerated).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PASRITAMIG/PLACEBO 300MG (78278343PCR3001/PRO00041362/EFSTATHIOU)	Medications	300 mg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	94 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
End of Treatment Visit	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:8278343PCR3001_Efstathiou
		  	ONC NURSING COMMUNICATION 35	Interval: Until discontinued	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for ***pasritamig/placebo*** Treatment: Refer to Section (***6.6 DOSE MODIFICATION***) 
Protocol Access Hyperlink:  [CG1]  78278343PCR3001_Efstathiou 

 [CG1]IT Beacon- Please use heading and add hyperlink:  78278343PCR3001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Physical examination.Symptom and disease-directed physical examinations at each study visit and include an evaluation of organ systems noted to be abnormal or involved, and of clinically relevant abnormalities in any organ
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2. To be performed pre-dose before every dose.
Post-dose vital signs assessments should be performed every hour (±30 minutes) for at least the first 2 hours post-dose for SU1, SU2, and first 2 target doses (C1D15 and C2D1). Following the third target dose (C3D1), vitals can be monitored post-infusion if clinically indicated.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ICE tool.When clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: Until discontinued	Occurrences: --	Comments:	ECOG. Pre-dose
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Events.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Concomitant therapy.Collected continuously after obtaining informed consent until 42 days after the last dose of study treatment or until starting subsequent treatment for prostate cancer, whichever occurs first. In follow-up, related SAEs should continue to be reported
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent.
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Symptomatic progression and skeletal related events are collected until participant has at least 1 event
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	If blood sampling or vital sign measurement is scheduled for the same time point as ECG recording, the procedures should be performed in the following order: ECG, vital signs, blood draw. WHEN CLINICALLY INDICATED
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	LDH	Interval: --	Occurrences: --	Comments:	Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease.
Perform labs pre-dose on the same date of study treatment administration or up to 3 days before.
Exception: Hematology and chemistry labs need to meet study inclusion/exclusion criteria within 7 days prior to randomization and do not need to be repeated for C1D1
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Central laboratory will be used for PSA assessment starting C1D1. Local PSA will be allowed during screening and on treatment if central PSA is not available.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect Day 1 (within 15 minutes of end of infusion) of Cycle 1, Cycle 2, and Cycle 3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose.Immunogenicity.At timepoints when both PK and immunogenicity samples are to be collected, aliquot(s) from PK samples will be used for immunogenicity assessments. No separate blood sample collection required.
					
Follow-up (Every 12 Weeks)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: Until discontinued	Occurrences: --	Comments:	PRO Assessments