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OP RSH PRO00041362 EFSTATHIOU 78278343PCR3001 SCREENING	

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

LESS than or EQUAL to 42 days Prior to Randomization	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
			Imaging
☑	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Disease burden to be assessed using CT. MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT scan. In any case, where an MRI is desirable, it must be the imaging technique used to assess disease at baseline and at all subsequent response evaluations. For all other sites of disease, MRI assessments do not replace the required chest, abdomen, and pelvic CT scans, unless CT scan is contraindicated.
		☑	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:	Disease burden to be assessed using CT. MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT scan. In any case, where an MRI is desirable, it must be the imaging technique used to assess disease at baseline and at all subsequent response evaluations. For all other sites of disease, MRI assessments do not replace the required chest, abdomen, and pelvic CT scans, unless CT scan is contraindicated.
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Disease burden to be assessed using CT. MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT scan. In any case, where an MRI is desirable, it must be the imaging technique used to assess disease at baseline and at all subsequent response evaluations. For all other sites of disease, MRI assessments do not replace the required chest, abdomen, and pelvic CT scans, unless CT scan is contraindicated.
					
LESS than or EQUAL to 28 days	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	Interval: --	Occurrences: --	Comments:	Informed consent.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria
		  	ONC NURSING COMMUNICATION 36	Interval: Until discontinued	Occurrences: --	Comments:	Demographics, medical history, disease characteristics
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Randomization:Commence study treatment within 3 calendar days after randomization
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Complete physical examination
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	ICE tool:Perform at screening to establish baseline neurologic status and then as clinically indicated
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 34	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
		  	ONC NURSING COMMUNICATION 47	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
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Medical Resource Utilization.Collected continuously after obtaining informed consent
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, heart rate, blood pressure, SpO2
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --			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:	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:	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: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	"if congenital nonhemolytic hyperbilirubinemia such as Gilbert's disease"
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --	Comments:	No testing is required unless mandated by the local health authority. See Sections 8.1.14 and 8.1.15
		  	HEPATITIS C VIRUS (HCV) RNA, DIAGNOSIS	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	No testing is required unless mandated by the local health authority. See Sections 8.1.14 and 8.1.15
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B VIRUS DNA, QUANTITATIVE, REAL-TIME PCR (WITH LABCORP SERIAL MONITORING)	Interval: --	Occurrences: --