Protocol Index	

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OP RSH PRO00038438 / EFSTATHIOU D9723C00001 SCREENING	

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

Baseline/Screening	Repeat 1 time	Cycle length: 28 days	-28 to -1 Days	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 22	Interval: --	Occurrences: --	Comments:	Potential participants will undergo prospective central HRRm testing, which may occur prior to the main screening period based on a separate informed consent (HRRm testing informed consent form). HRRm testing must be completed and have a known result prior to randomisation. Participants will be allocated to one of the 2 cohorts (HRRm or Non-HRRm) based on the result of central HRRm testing
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Informed consent: HRRm testing
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Adverse Events review

At the HRRm testing visit collect SAEs and AEs relating to study procedures only
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Mandatory FFPE tumour sample 

For central tissue HRRm testing and complementary or companion diagnostic development
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Mandatory blood sample for central ctDNA HRRm testing 

For central ctDNA HRRm testing
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Mandatory blood sample 

For complementary or companion diagnostic development
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Informed consent: Main Study
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Informed consent: genetic sample and analysis for Genomic Initiative (optional)
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria
			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
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Current Medical Conditions
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Demography
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Physical examination
			Nursing Orders
  	MEASURE HEIGHT AND LENGTH	Interval: --	Occurrences: --	Comments:	Height
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	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:	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:	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:	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: --		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --			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
			Imaging
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PSMA-PET 

Optional where available. If performed as part of local standard of care at baseline and/or during subsequent visits, this information will be collected and images should be submitted
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	VITAMIN B12 LEVEL	Interval: --	Occurrences: --		  	FOLATE LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	LIPID PANEL	Interval: --	Occurrences: --			Labs
  	C-REACTIVE PROTEIN	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: --