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OP RSH PRO00038438 / EFSTATHIOU D9723C00001 ARM 2 PLAN D	

Types:      Research Oncology Treatment
Synonyms:  SARUPARIB, AZD5305, EVOPAR-PROSTATE01

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria

Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed.
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Randomization
Every effort should be made to minimise the time between randomisation and starting treatment (ie, within 3 business days of randomisation).
			Nursing Orders
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Medical History

Includes substance usage, family history of premature CV disease; and details of any blood transfusions performed within the 120 days prior to the start of the study intervention and the reasons, eg, bleeding or myelosuppression.
Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Current Medical Conditions

Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination
Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed. If a participant receiving abiraterone is considered to have a significant risk of congestive heart failure due to risk of fluid retention, consider close monitoring per local practice.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: Predose
ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: Predose
ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: Predose
ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 1 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 1 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 1 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 3 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 3 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 3 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	C1D1: 1, 3 hr
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	ePRO training and setup
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	BPI-SF item 3 (Worst pain), Analgesic log (captured on ePRO device)

To be completed daily for 7 consecutive days every 8 weeks from the C1D1 dosing date, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	PROMIS PF CAT		

To be completed every 14 weeks from C1D1 dosing date until treatment discontinuation in regions where assessment is available, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S						Day 15	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: Predose
ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: Predose
ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: Predose
ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 1 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 1 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 1 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 3 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 3 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	C1D1: 3 hr

ECGs at Screening, C1D1, and C2D1 will be performed in triplicate and performed 5 mins apart (footnote j on page 43)
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	C2D1: 1, 3 hr
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S						Day 15	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	BPI-SF item 3 (Worst pain), Analgesic log (captured on ePRO device)

To be completed daily for 7 consecutive days every 8 weeks from the C1D1 dosing date, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S						Day 15	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Imaging
  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	PCWG3 assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	PROMIS PF CAT		

To be completed every 14 weeks from C1D1 dosing date until treatment discontinuation in regions where assessment is available, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S							
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	BPI-SF item 3 (Worst pain), Analgesic log (captured on ePRO device)

To be completed daily for 7 consecutive days every 8 weeks from the C1D1 dosing date, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S							
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	BPI-SF item 3 (Worst pain), Analgesic log (captured on ePRO device)

To be completed daily for 7 consecutive days every 8 weeks from the C1D1 dosing date, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S							
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	BPI-SF item 3 (Worst pain), Analgesic log (captured on ePRO device)

To be completed daily for 7 consecutive days every 8 weeks from the C1D1 dosing date, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S							
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Imaging
  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	PCWG3 assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	PROMIS PF CAT		

To be completed every 14 weeks from C1D1 dosing date until treatment discontinuation in regions where assessment is available, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S							
Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	BPI-SF item 3 (Worst pain), Analgesic log (captured on ePRO device)

To be completed daily for 7 consecutive days every 8 weeks from the C1D1 dosing date, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S							
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	BPI-SF item 3 (Worst pain), Analgesic log (captured on ePRO device)

To be completed daily for 7 consecutive days every 8 weeks from the C1D1 dosing date, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S							
Cycle 11	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	BPI-SF item 3 (Worst pain), Analgesic log (captured on ePRO device)

To be completed daily for 7 consecutive days every 8 weeks from the C1D1 dosing date, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S							
Cycle 12	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination

as clinically indicated,
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature. Vital signs (to be taken before blood collection for laboratory tests)
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Imaging
  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	PCWG3 assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	At all tumour imaging timepoints (±14 days).  Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	PROMIS PF CAT		

To be completed every 14 weeks from C1D1 dosing date until treatment discontinuation in regions where assessment is available, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Saruparib/Placebo 60 mg orally daily for D1- D28.

Saruparib/placebo: take with or without food, except on C1D1 and C2D1 when saruparib/placebo should be taken on an empty stomach (no food/drink other than water 2 hours prior and at least 1 hour after dosing)
		  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Saruparib/placebo: drugs causing QT prolongation and have a known risk of TdP are prohibited
		  	ONC NURSING COMMUNICATION 63	Interval: --	Occurrences: --	Comments:	saruparib/placebo: this agent has multiple potential for drug interactions; strong inhibitors and inducers of CYP3A4 should not be combined with saruparib. Strong inducers/inhibitors of CYP3A4 should be stopped at least 21 days before first dose until 30 days after last dose of medication.
		  	ONC NURSING COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	educate patient on the risk of hematological toxicity (thrombocytopenia, neutropenia, anemia), nausea/vomiting, fatigue and asthenia
		  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Saruparib/placebo should be discontinued for a min 7 days before palliative radiation treatment and restarted within 4 weeks from the end of radiotherapy
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	notify provider if ASL or ALT > 3 x ULN together with tot bil > 2 x ULN
			Chemotherapy
  	abiraterone (ZYTIGA) chemo tablet 1,000 mg	Dose: 1,000 mg	Route: oral	daily	Start: S			Instructions:	[D1 - D28]  Take on an empty stomach  (no food 2 hours prior and 1 hour after the dose of abiraterone)- tablet should be swallowed whole and not crushed or chewed 		  	predniSONE (DELTASONE) tablet 5 mg	Dose: 5 mg	Route: oral	daily	Start: S							
EOT/Disease Progression	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination
Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed. If a participant receiving abiraterone is considered to have a significant risk of congestive heart failure due to risk of fluid retention, consider close monitoring per local practice.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Imaging
  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
		  	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI tumor imaging (RECIST 1.1)
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	PCWG3 assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Labs
  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Those participants taking part in the study via the decentralised model will not be required to provide these samples after Cycle 14 (but will at progression). The longitudinal ctDNA samples should be collected from all participants who have discontinued study intervention (whether for one or both of saruparib/placebo and physician's choice NHA) due to an AE and who continue to attend study visits and undergo scans.
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	BPI-SF item 3 (Worst pain), Analgesic log (captured on ePRO device)

To be completed daily for 7 consecutive days every 8 weeks from the C1D1 dosing date, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC IL 166, BPI-SF, PROMIS 7A, EORTC IL 319, PGI-S

Every 4 weeks from the C1D1 dosing date until Week 52, then every 8 weeks, at treatment discontinuation, and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EORTC IL 320, PGI-TT

To be completed by participant every week until Week 12, then every 4 weeks, from the C1D1 dosing date until treatment discontinuation, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	PROMIS PF 8C

To be completed every 4 weeks until Week 52; then every 8 weeks, from the baseline C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	PROMIS PF CAT		

To be completed every 14 weeks from C1D1 dosing date until treatment discontinuation in regions where assessment is available, at treatment discontinuation and disease progression
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	EQ-5D-5L 
EORTC IL6

Collect every 8 weeks from C1D1 dosing date, at treatment discontinuation and disease progression, until a) 6 months post radiographically confirmed disease progression or b) upon initiation of subsequent non-protocol-specified anticancer therapy
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit
					
Safety Follow Up	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   D9723C00001_Efstathiou
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for SARUPARIB Treatment: Refer to Section 6.6 (Dose Modification) Management of AEs Associated with SARUPARIB
Protocol Access Hyperlink: [CG1]  D9723C00001_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Event Review
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination
Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed.
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Screening assessments that have been performed within 7 days prior to starting study intervention do not have to be repeated at Cycle 1 Day 1 if the participant's condition has not changed. If a participant receiving abiraterone is considered to have a significant risk of congestive heart failure due to risk of fluid retention, consider close monitoring per local practice.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	BP, pulse rate and body temperature.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 66	Interval: --	Occurrences: --	Comments:	Subsequent anticancer therapy use (including surgery and radiation therapy)
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	FOLATE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
					
Survival Follow Up	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Symptomatic skeletal event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 66	Interval: --	Occurrences: --	Comments:	Subsequent anticancer therapy use (including surgery and radiation therapy)
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	PFS2
		  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Survival Status
			Nursing Orders
  	ONC NURSING COMMUNICATION 60	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD) review

At every visit and may be conducted by phone if not tied to a visit