Protocol Index	

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OP RESEARCH PRO00036218 BAYER 21516 SCREENING / BASELINE EFSTATHIOU	

Types:      Research Oncology Treatment
Synonyms:  

Screening 	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treatment team to obtain informed consent. 
o Up to 28 days before any protocol specific procedures are performed. 
o The ICF must be signed before any protocol-specified procedures are performed.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Obatin up to 28 days before WK1/D1.  
1. Eligibility criteria.  
2. Demography. 
3. Medical history. 
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain prostate Cancer history (incl. pre-treatments and procedures). Up to 28 days before WK1/D1.
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	Up to 28 days before WK1/D1. 
A left ventricular fraction ejection will be assessed at baseline. Follow up as needed at the discretion of the investigator.
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Study team to obtain 12- Lead ECG. 
o Up to 7 days before WK1/D1. 
o Ensure that ECG and vital signs are collected prior to blood draw.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain. AEs/SAEs. Up to 28/7 days before WK1/D1.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain concomitant treatments including bone health agents (BHA) according to local guidelines for participants with risk of bone fracture. Up to 28/7 days before WK1/D1.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Obtain physical examination including skin, weight and height. Up to 28 days before WK1/D1.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Include temperature, systolic and diastolic blood pressure, and heart rate. Up to 7 days before WK1/D1.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Laboratory safety assessments. Up to 28 days before WK1/D1. 
Study Team CRC and Treating team to obtain laboratory safety assessments . For the Following to be sent to Central Laboratory: Hematology, general chemistry, liver chemistries, coagulation, PSA, Testosterone.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	ECOG PS. Up to 28 days before WK1/D1.
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Up to 28 days before WK1/D1.
		  	TESTOSTERONE, TOTAL, IMMUNOASSAY (FOR ADULT MALES)	Interval: --	Occurrences: --	Comments:	Up to 28 days before WK1/D1.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain the Following to be sent to Central Laboratory: Hematology, general chemistry, liver chemistries, coagulation, PSA, Testosterone.
			Imaging
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Contrast-enhanced chest, abdomen, and pelvic CT or MRI and bone scan will be performed at baseline to demonstrate metastatic disease. If androgen deprivation therapy has not commenced, scans must be obtained within 6 weeks of enrollment. If androgen deprivation has commenced prior to enrollment, scans must be obtained within 6 weeks prior to the start of androgen deprivation therapy. If all required imaging had not been completed prior to starting androgen deprivation, then any additional scans must be obtained after starting androgen deprivation but prior to enrollment. 
		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Provide prescription for ODM-201 (Darolutamide) 600 mg PO BID until EOT. Start within 3 days from enrollment.