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OP RESEARCH PRO00031037 NCT04513717 ARM 4 HAQUE	

Types:      Research Oncology Treatment
Synonyms:  NRG-GU009

Prior to Step 1 Registration 1 @ 1 Days (<120 Days Prior)	Repeat 1 time	Cycle length: 120 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	o Informed Consent 
o Inclusion/Exclusion Criteria  
o Subject Demographics
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	ACE-27 Score form
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	HIV/HBV Viral testing documentation
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Or NaF PET. Please order as appropriate.
					
Prior to Step 2 Randomization  1 @1Days (<-180 days prior)	Repeat 1 time	Cycle length: 179 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Mandatory Decipher Analysis
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	QOL forms; EPIC-26, FACIT-Cog, PROMIS-Fatigue Short Form, PROMIS-Depression
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	QOL form submission
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Randomization
					
Prior to RT Treatment 1@ 1Days (Baseline/Prior to RT Treatment)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Mandatory Decipher Analysis
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	H&E slide and corresponding FFPE Block
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	QOL forms; EPIC-26, FACIT-Cog, PROMIS-Fatigue Short Form, PROMIS-Depression
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Radiation Therapy Consult
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	BONE DENSITY	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	F-18 Fluciclovine PET CT for patients who consent + Contrast Agent. Please order as appropriate.
					
Radiation Therapy 1:9 @ 9Weeks (2 to 9 weeks of treatment)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	o External Beam Radiation Therapy (EBRT). Will be performed by ARIA.  
o Brachytherapy. Will be performed by ARIA.
					
Day 0	Repeat 1 time	Cycle length: 6 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
After End of RT 1 @ 1Days (D7)	Repeat 1 time	Cycle length: 6 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order androgen deprivation therapy via Therapy Plans as appropriate.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Day 14	Repeat 1 time	Cycle length: 14 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	QOL form submission
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Reminder to administer one of the androgen deprivation therapies. Please order via Therapy Plan. 
o Leuprolide (INJ): Suggested therapy per PI.
o Degarelix (INJ); 
o Triptorelin (INJ); 
o Goserelin (INJ); 
o Apalutamide (PO): will be ordered using a paper Prescription Order Form to IDS Pharmacy; 
o Bicalutamide (PO); 
o Buserelin (INJ); 
o Histrelin (INJ).
					
Month 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	QOL form submission
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Or NaF PET. Please order as appropriate.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Reminder to administer one of the androgen deprivation therapies. Please order via Therapy Plan. 
o Leuprolide (INJ): Suggested therapy per PI.
o Degarelix (INJ); 
o Triptorelin (INJ); 
o Goserelin (INJ); 
o Apalutamide (PO): will be ordered using a paper Prescription Order Form to IDS Pharmacy; 
o Bicalutamide (PO); 
o Buserelin (INJ); 
o Histrelin (INJ).
					
Month 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	QOL form submission
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Reminder to administer one of the androgen deprivation therapies. Please order via Therapy Plan. 
o Leuprolide (INJ): Suggested therapy per PI.
o Degarelix (INJ); 
o Triptorelin (INJ); 
o Goserelin (INJ); 
o Apalutamide (PO): will be ordered using a paper Prescription Order Form to IDS Pharmacy; 
o Bicalutamide (PO); 
o Buserelin (INJ); 
o Histrelin (INJ).
					
Month 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 11	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 12	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	QOL form submission
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	QOL forms; EPIC-26, FACIT-Cog, PROMIS-Fatigue Short Form, PROMIS-Depression
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Or NaF PET. Please order as appropriate.
			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Reminder to administer one of the androgen deprivation therapies. Please order via Therapy Plan. 
o Leuprolide (INJ): Suggested therapy per PI.
o Degarelix (INJ); 
o Triptorelin (INJ); 
o Goserelin (INJ); 
o Apalutamide (PO): will be ordered using a paper Prescription Order Form to IDS Pharmacy; 
o Bicalutamide (PO); 
o Buserelin (INJ); 
o Histrelin (INJ).
					
Month 13	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 14	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 15	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	QOL form submission
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Reminder to administer one of the androgen deprivation therapies. Please order via Therapy Plan. 
o Leuprolide (INJ): Suggested therapy per PI.
o Degarelix (INJ); 
o Triptorelin (INJ); 
o Goserelin (INJ); 
o Apalutamide (PO): will be ordered using a paper Prescription Order Form to IDS Pharmacy; 
o Bicalutamide (PO); 
o Buserelin (INJ); 
o Histrelin (INJ).
					
Month 16	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 17	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 18	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	QOL form submission
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Or NaF PET. Please order as appropriate.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Reminder to administer one of the androgen deprivation therapies. Please order via Therapy Plan. 
o Leuprolide (INJ): Suggested therapy per PI.
o Degarelix (INJ); 
o Triptorelin (INJ); 
o Goserelin (INJ); 
o Apalutamide (PO): will be ordered using a paper Prescription Order Form to IDS Pharmacy; 
o Bicalutamide (PO); 
o Buserelin (INJ); 
o Histrelin (INJ).
					
Month 19	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 20	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 21	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	QOL form submission
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Reminder to administer one of the androgen deprivation therapies. Please order via Therapy Plan. 
o Leuprolide (INJ): Suggested therapy per PI.
o Degarelix (INJ); 
o Triptorelin (INJ); 
o Goserelin (INJ); 
o Apalutamide (PO): will be ordered using a paper Prescription Order Form to IDS Pharmacy; 
o Bicalutamide (PO); 
o Buserelin (INJ); 
o Histrelin (INJ).
					
Month 22	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 23	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 24	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Skin Rash - 
Grade 1: 
o Continue Apalutamide at current dose. 
o Initiate Dermatological Treatment 1. Topical Steroid Cream And 2. Oral Antihistamines. o Monitor for Change in Severity.

Grade 2 (Symptomatic Grade 1): 
o Hold Apalutamide for up to 28 Days. 
o Initiate Dermatological Treatment. 1. Topical Steroid Cream And 2. Oral Antihistamines. 
o If after 28 Days, rash has not resolved to Grade LESS than 1, contact study Medical Oncology Co-chair, Oliver Sartor, MD, to discuss further management and possible discontinuation of study drug. 
o Monitor for change in severity. 
o If rash or related symptoms improve, reinitiate Apalutamide when rash is Grade <1. Consider dose reduction at a 1 dose level reduction. 

Grade GREATER than or EQAUL to 3:
o Hold apalutamide for up to 28 days. 
o Initiate dermatological treatment. 1. Topical steroid cream AND 2. Oral Antihistamines AND 3. Consider short course of oral steroids. 
o Reassess after 2 weeks (by site staff), and if the rash is the same or has worsened, initiate oral steroids (if not already done) and refer the subject to a dermatologist. 
o Reinitiate apalutamide at a 1 dose level reductione when rash is Grade LESS than or EQUAL to 1.
o If the dose reduction will lead to a dose less than 120mg, the study drug must be stopped (discontinued).
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	Note: Rash may be graded differently according to the type of rash and associated symptoms. For example, maculo-papular rash is graded by body surface area covered and not severity of the rash. Please consult NCI-CTCAE Version 5 for specific grading criteria for other types of rash. 
a. Obtain bacterial/viral cultures if infection is suspected; 
b. Subject presents with other rash related symptoms such as pruritus, stinging, or burning; 
c. 1 dose level reduction = 60mg (1 apalutamide tablet); 
d. If there is blistering or mucosal involvement, stop apalutamide dosing immediately and contact PI; 
e. If a subject previously started oral corticosteroids, continue for at least 1 week after resumption of reduced dose of apalutamide. If the proposed total oral steroid use will exceed 28 days, contact the Medical Oncology Co-chair, Oliver Sartor, MD.
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First occurrence of seizure of any grade or Grade 4 neurotoxicity: Discontinue.
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Hypertension and Edema/Fluid Retention Attributed to Apalutamide. 
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: No change to Apalutamide. 
o First Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Second Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: No change to Apalutamide.
		  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	All Other Adverse Events Attributed to Apalutamide.
o Grade 1 or 2: No change to Apalutamide. 
o Grade GREATER than or EQAUL to 3: Hold until Grade 1 or baseline, reduce to dose level -1. 
o First Recurrence GREATER than or EQUAL to Grade 3: Hold until Grade 1 or baseline, reduce to dose level -2. 
o Second Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o Thrid Recurrence GREATER than or EQUAL to Grade 3: Discontinue. 
o First Occurrence of Seizure of any grade or Grade 4 Neurotoxicity: Discontinue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	QOL form submission
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	QOL forms; EPIC-26, FACIT-Cog, PROMIS-Fatigue Short Form, PROMIS-Depression
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Apalutamide PO will be ordered using a paper Prescription Order Form to IDS Pharmacy.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Or NaF PET. Please order as appropriate.
			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Imaging
  	BONE DENSITY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	F-18 Fluciclovine PET CT for patients who consent + Contrast Agent. Please order as appropriate.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Reminder to administer one of the androgen deprivation therapies. Please order via Therapy Plan. 
o Leuprolide (INJ): Suggested therapy per PI.
o Degarelix (INJ); 
o Triptorelin (INJ); 
o Goserelin (INJ); 
o Apalutamide (PO): will be ordered using a paper Prescription Order Form to IDS Pharmacy; 
o Bicalutamide (PO); 
o Buserelin (INJ); 
o Histrelin (INJ).
					
Month 30	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	QOL forms; EPIC-26, FACIT-Cog, PROMIS-Fatigue Short Form, PROMIS-Depression
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
			Labs
☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		☑	T4, FREE	Interval: --	Occurrences: --		☐	T3	Interval: --	Occurrences: --	Comments:	If clinically indicated
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --					
Month 36	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	QOL forms; EPIC-26, FACIT-Cog, PROMIS-Fatigue Short Form, PROMIS-Depression
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Or NaF PET. Please order as appropriate.
			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Imaging
  	BONE DENSITY	Interval: --	Occurrences: --					
Month 42	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --					
Month 48	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --					
Month 54	Repeat 1 time	Cycle length: 168 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --					
Month 60	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Cardiac and Comorbidity Event Assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Venipuncture
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessments
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	QOL forms; EPIC-26, FACIT-Cog, PROMIS-Fatigue Short Form, PROMIS-Depression
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	History and Physical Exam (to include prostate exam, weight, height, waist measurement at belly button, blood pressure)
			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Labs
  	PSA, TOTAL AND FREE	Interval: --	Occurrences: --			Imaging
  	BONE DENSITY	Interval: --	Occurrences: --