Protocol Index	

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OP RESEARCH PRO00036218 BAYER 21516 EFSTATHIOU	

Types:      Research Oncology Treatment
Synonyms:  

Cycles 1 to 9	Repeat 9 times	Cycle length: 84 days	Day 1	Perform every 1 day x1		Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Treatment Conditions/Parameters for Darolutamide (ODM-201): Dose Modification Guidelines for Adverse Events. 
For dose modifications, refer to the US Prescribing Information for Darolutamide. Toxicities will be graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 5.0.
			Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Physical examination (including skin, weight and height). Until PSA or clinical progression.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain 12-lead ECG if clinically indicated. 
Ensure that ECG is ccollected prior to blood draw. An ECG is to be performed at subsequent visits if indicated by the investigator. 
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Include temperature, systolic and diastolic blood pressure, and heart rate. 
Ensure viatls are ccollected prior to blood draw.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain the Following: AE Review and SAE Review. 
SAEs, regardless of causality assessment, must be collected through the termination visit and for 30 days following the study drug discontinuation, whichever is longer. Any SAE judged by the investigator to be related to the study treatment should be reported regardless of the length of the time that has passed since the study completion.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain concomitant treatments.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG PS
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Administer Darolutamide orally as prescribed.
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Until PSA or clinical progression.
		  	TESTOSTERONE, TOTAL, IMMUNOASSAY (FOR ADULT MALES)	Interval: --	Occurrences: --	Comments:	Until PSA or clinical progression.
		  	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 3	Interval: --	Occurrences: --	Comments:	Can be performed at any time in case of PSA progression, symptomatic progressive disease, start of new antineoplastic therapy, or if recommended as part of standard of care procedure. All tumor assessment imaging, whenever conducted per investigator's discretion, must be assessed for radiographic progression by a radiologist or the investigator, according to RECIST criteria (v. 1.1) for soft tissue metastases and PCWG3 criteria for bone metastases, until radiographic progression or start of new antineoplastic therapy. This applies to participants who enter the Active Follow-up or Survival Follow-up.
		☑	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: --					
Cycle 10	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Treatment Conditions/Parameters for Darolutamide (ODM-201): Dose Modification Guidelines for Adverse Events. 
For dose modifications, refer to the US Prescribing Information for Darolutamide. Toxicities will be graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 5.0.
			Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Physical examination (including skin, weight and height). Until PSA or clinical progression.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain 12-lead ECG if clinically indicated. 
Ensure that ECG is ccollected prior to blood draw. An ECG is to be performed at subsequent visits if indicated by the investigator. 
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Include temperature, systolic and diastolic blood pressure, and heart rate. 
Ensure viatls are ccollected prior to blood draw.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain the Following: AE Review and SAE Review. 
SAEs, regardless of causality assessment, must be collected through the termination visit and for 30 days following the study drug discontinuation, whichever is longer. Any SAE judged by the investigator to be related to the study treatment should be reported regardless of the length of the time that has passed since the study completion.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain concomitant treatments.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG PS
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Administer Darolutamide orally as prescribed.
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Until PSA or clinical progression.
		  	TESTOSTERONE, TOTAL, IMMUNOASSAY (FOR ADULT MALES)	Interval: --	Occurrences: --	Comments:	Until PSA or clinical progression.
		  	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 3	Interval: --	Occurrences: --	Comments:	Can be performed at any time in case of PSA progression, symptomatic progressive disease, start of new antineoplastic therapy, or if recommended as part of standard of care procedure. All tumor assessment imaging, whenever conducted per investigator's discretion, must be assessed for radiographic progression by a radiologist or the investigator, according to RECIST criteria (v. 1.1) for soft tissue metastases and PCWG3 criteria for bone metastases, until radiographic progression or start of new antineoplastic therapy. This applies to participants who enter the Active Follow-up or Survival Follow-up.
		☑	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: --					
EOT	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Physical examination (including skin, weight and height). Until PSA or clinical progression.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain 12-lead ECG if clinically indicated. 
Ensure that ECG is ccollected prior to blood draw. An ECG is to be performed at subsequent visits if indicated by the investigator. 
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Include temperature, systolic and diastolic blood pressure, and heart rate. 
Ensure viatls are ccollected prior to blood draw.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain the Following: AE Review and SAE Review. 
SAEs, regardless of causality assessment, must be collected through the termination visit and for 30 days following the study drug discontinuation, whichever is longer. Any SAE judged by the investigator to be related to the study treatment should be reported regardless of the length of the time that has passed since the study completion.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain concomitant treatments.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG PS
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Until PSA or clinical progression.
		  	TESTOSTERONE, TOTAL, IMMUNOASSAY (FOR ADULT MALES)	Interval: --	Occurrences: --	Comments:	Until PSA or clinical progression.
		  	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 3	Interval: --	Occurrences: --	Comments:	Can be performed at any time in case of PSA progression, symptomatic progressive disease, start of new antineoplastic therapy, or if recommended as part of standard of care procedure. All tumor assessment imaging, whenever conducted per investigator's discretion, must be assessed for radiographic progression by a radiologist or the investigator, according to RECIST criteria (v. 1.1) for soft tissue metastases and PCWG3 criteria for bone metastases, until radiographic progression or start of new antineoplastic therapy. This applies to participants who enter the Active Follow-up or Survival Follow-up.
		☑	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: --					
Follow Up	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Physical examination (including skin, weight and height). Until PSA or clinical progression.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain the Following: AE Review and SAE Review. 
SAEs, regardless of causality assessment, must be collected through the termination visit and for 30 days following the study drug discontinuation, whichever is longer. Any SAE judged by the investigator to be related to the study treatment should be reported regardless of the length of the time that has passed since the study completion.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain concomitant treatments.
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Subsequent antineoplastic therapy assessment until PSA or clinical progression. Use of post-study antineoplastic therapy will also be collected for participants with hormone refractory disease.
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	Until PSA or clinical progression.
		  	TESTOSTERONE, TOTAL, IMMUNOASSAY (FOR ADULT MALES)	Interval: --	Occurrences: --	Comments:	Until PSA or clinical progression.
			Imaging
☑	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Can be performed at any time in case of PSA progression, symptomatic progressive disease, start of new antineoplastic therapy, or if recommended as part of standard of care procedure. All tumor assessment imaging, whenever conducted per investigator's discretion, must be assessed for radiographic progression by a radiologist or the investigator, according to RECIST criteria (v. 1.1) for soft tissue metastases and PCWG3 criteria for bone metastases, until radiographic progression or start of new antineoplastic therapy. This applies to participants who enter the Active Follow-up or Survival Follow-up.
		☑	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: --					
Survival Follow Up	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain the Following: AE Review and SAE Review. 
SAEs, regardless of causality assessment, must be collected through the termination visit and for 30 days following the study drug discontinuation, whichever is longer. Any SAE judged by the investigator to be related to the study treatment should be reported regardless of the length of the time that has passed since the study completion.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Study Team CRC and Treating team to obtain concomitant treatments. 
Concomitant medications during Survival Follow-up will be collected for treatment of related SAEs only. 
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Survival status. 
Participants who are ongoing at the time of primary endpoint data cutoff will be followed up for survival for up to 24 months from study entry of the last participant. 
			Imaging
☑	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Can be performed at any time in case of PSA progression, symptomatic progressive disease, start of new antineoplastic therapy, or if recommended as part of standard of care procedure. All tumor assessment imaging, whenever conducted per investigator's discretion, must be assessed for radiographic progression by a radiologist or the investigator, according to RECIST criteria (v. 1.1) for soft tissue metastases and PCWG3 criteria for bone metastases, until radiographic progression or start of new antineoplastic therapy. This applies to participants who enter the Active Follow-up or Survival Follow-up.
		☐	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: --