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. 2024 Mar 14;42(14):1687–1698. doi: 10.1200/JCO.23.02105

TABLE A1.

Characteristics of the Pooled Trials

Clinical Trial Study Population PARPi Arm Control Arm Stratification Factors HRR Genes Diagnostic Assays Imaging Interval
PROfound37 Second-line mCRPC Olaparib Abiraterone or enzalutamide Previous taxane (yes v no)
Measurable disease (yes v no)
ATM
BRCA1
BRCA2
BRIP1
BARD1
CDK12
CHEK1
CHEK2
FANCL
PALB2
PPP2R2A
RAD51B
RAD51C
RAD51D
RAD54L
FoundationOne CDx; FoundationOne Liquid CDx CT/MRI and bone scan; every 8 weeks (±7 days) relative to the date of random assignment, until disease progression by BICR
PROpel20 First-line mCRPC Olaparib plus abiraterone Abiraterone plus placebo Metastases (bone only v visceral v other)
Docetaxel treatment at mCSPC stage (yes v no)
ATM
BRCA1
BRCA2
BARD1
BRIP1
CDK12
CHEK1
CHEK2
FANCL
PALB2
RAD51B
RAD51C
RAD51D
RAD54L
FoundationOne CDx; FoundationOne Liquid CDx CT/MRI and bone scan; every 8 weeks (±7 days) for the first 24 weeks, then every 12 weeks (±7 days) relative to the date of random assignment
TALAPRO-238 First-line mCRPC Talazoparib plus enzalutamide Enzalutamide plus placebo HRR gene alteration status (HRRm v non-HRRm v unknown)
Previous treatment with life-prolonging therapy (docetaxel or abiraterone, or both) in the castration-sensitive setting (yes v no)
ATM
ATR
BRCA1
BRCA2
CDK12
CHEK2
FANCA
NBN
MLH1
MRE11A
PALB2
RAD51C
FoundationOne CDx; FoundationOne Liquid CDx CT/MRI and bone scan; every 8 weeks through week 25 and then every 12 weeks until radiographic progression is determined by investigator (part 1) or by investigator and BICR (part 2)
MAGNITUDE39 First-line mCRPC Niraparib plus abiraterone Abiraterone plus placebo Cohort 1 and 2:
 Previous treatment with taxane-based chemotherapy (yes v no)
 Previous treatment with novel antiandrogen therapy such as enzalutamide, apalutamide, and darolutamide (yes v no)
 Previous treatment with abiraterone (yes v no).
Cohort 1 only:
 Gene alteration group (BRCAm v non-BRCA HRRm)
ATM
BRCA1
BRCA2
BRIP1
CDK12
CHEK2
FANCA
HDAC2
PALB2
FoundationOne CDx; Resolution Bioscience HRD plasma test; AmoyDx blood and tissue assays; Accredited local laboratory tests CT/MRI and bone scan; at cycle 3 day 1, cycle 5 day 1, cycle 7 day 1, and then every 12 weeks until radiographic progression (a treatment cycle was defined as 28 days)
TRITON-240 ≥Second-line mCRPC Rucaparib NA (single-arm trial) NA (single-arm trial) ATM
BRCA1
BRCA2
BARD1
BRIP1
CDK12
CHEK2
FANCA
NBN
PALB2
RAD51
RAD51B
RAD51C
RAD51D
RAD54L
Central testing by Foundation Medicine. Germline testing was performed by Color Genomics CT and bone scan (MRI, X-ray, PET-CT, and ultrasound if required); every 8 weeks for up to 24 weeks, then every 12 weeks
TALAPRO-121 ≥Second-line mCRPC Talazoparib NA (single-arm trial) NA (single-arm trial) ATM
ATR
BRCA1
BRCA2
CHEK2
FANCA
MLH1
MRE11A
NBN
PALB2
RAD51C
FoundationOne CDx CT/MRI and bone scan; every 8 weeks through week 25, then every 12 weeks thereafter

Abbreviations: BICR, blinded independent central review; CT, computed tomography; HRR, homologous recombination repair; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; MRI, magnetic resonance imaging; NA, not available; PARPi, poly(ADP-ribose) polymerase inhibitor; PET, positron emission tomography.