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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			Research tolerance: -0/+0 days	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			Research tolerance: -0/+0 days	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			Research tolerance: -0/+0 days	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			Research tolerance: -0/+0 days	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			Research tolerance: -0/+0 days	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: --					
Extension Phase – Treatment Period - Subsequent visits (every 12 weeks, ± 7 days)	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	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 35	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Must be collected through the last dose of study drug and for 30 days following the study drug discontinuation. After 30 days following study drug discontinuation, only any SAE judged by the investigator to be related to the study treatment must be reported up to the end of the study
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Darolutamide administration
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
Extension Phase – Treatment Period - Subsequent visits (every 12 weeks, ± 7 days)	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	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 35	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Must be collected through the last dose of study drug and for 30 days following the study drug discontinuation. After 30 days following study drug discontinuation, only any SAE judged by the investigator to be related to the study treatment must be reported up to the end of the study
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Darolutamide administration
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
Extension Phase – Treatment Period - Subsequent visits (every 12 weeks, ± 7 days)	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	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 35	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Must be collected through the last dose of study drug and for 30 days following the study drug discontinuation. After 30 days following study drug discontinuation, only any SAE judged by the investigator to be related to the study treatment must be reported up to the end of the study
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Darolutamide administration
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
Extension Phase – Treatment Period - Subsequent visits (every 12 weeks, ± 7 days)	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	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 35	Interval: --	Occurrences: --	Comments:	AEs/SAEs. Must be collected through the last dose of study drug and for 30 days following the study drug discontinuation. After 30 days following study drug discontinuation, only any SAE judged by the investigator to be related to the study treatment must be reported up to the end of the study
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Darolutamide administration
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --					
Extension Phase – Post treatment /follow up - EOT visit (30 days (+7 days) after last dose of darolutamide)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Completed before starting a new antineoplastic therapy, if it starts sooner than 30 days (+7 days) after the last dose of study drug)
		  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	After EOT, the participants who discontinued darolutamide treatment for reasons other than death will need to be followed during the extension survival follow-up phase (Off study treatment) until documented death or study completion
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, blood pressure, heart rate. Collect prior to blood draw
		  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	AEs/SAEs.Must be collected through the last dose of study drug and for 30 days following the study drug discontinuation. After 30 days following study drug discontinuation, only any SAE judged by the investigator to be related to the study treatment must be reported up to the end of the study
		  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Concomitant medications
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	An ECG is to be performed at subsequent visits if indicated by the investigator. Collect prior to blood draw
					
Extension Phase – Post treatment /follow up - Survival Follow-up visits (approx. every 12 weeks until study completion)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	AEs/SAEs.Must be collected through the last dose of study drug and for 30 days following the study drug discontinuation. After 30 days following study drug discontinuation, only any SAE judged by the investigator to be related to the study treatment must be reported up to the end of the study
		  	ONC NURSING COMMUNICATION 70	Interval: --	Occurrences: --	Comments:	Concomitant medications.Concomitant medications in patients with related SAEs
		  	ONC NURSING COMMUNICATION 71	Interval: --	Occurrences: --	Comments:	Subsequent antineoplastic therapy assessment.Use of post-study antineoplastic therapy will be collected including for those participants with castrate resistant prostate cancer disease until the end of study.
		  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	Survival status. Survival follow-up visit may be performed by remote confirmation.