Table 2.

Phase I, II, or III trials assessing PARP inhibitors in combination with Antiandrogen therapy. Abbreviations: mCRPC = metastatic castration-resistant prostate cancer; mHSPC = metastatic hormone sensitive prostate cancer; enza = Enzalutamide; AAP = abiraterone plus prednisone; RT = radiotherapy; PFS = progression free survival; rPFS = radiological progression free survival; OS = overall survival; DLT = dose-limiting toxicity.

STUDY	DESIGN	Estimated Enrollment	Setting	Agent(s)	Homologous Recombination Repair Mutations	Primary Endpoint(s)
TALAPRO-2 NCT03395197	Phase III, randomized	872	mCRPC treatment naïve	Talazoparib + enza vs. placebo + enza	Selected	Safety, PFS
TALAPRO-3 NCT04821622	Phase III, randomized	550	mHSPC	Talazoparib + enza vs. placebo + enza	Selected	rPFS
NCT03012321	Phase II, randomized	70	mCRPC treatment naïve	Olaparib vs. AAP vs. olaparib + AAP	Selected	PFS
PROpel NCT03732820	Phase III, randomized	720	mCRPC treatment naïve	Olaparib + AAP vs. placebo + AAP	Unselected	rPFS
CASPAR NCT04455750	Phase III, randomized	1002	mCRPC treatment naive	Rucaparib + enza vs. placebo + enza	Unselected	rPFS, OS
MAGNITUDE NCT03748641	Phase III, randomized	1000	mCRPC treatment naïve	Niraparib + AAP vs. placebo + AAP	Selected	rPFS
NADIR NCT04037254	Phase II, randomized	180	High risk localized or locally advanced PCa (no prior treatment)	Niraparib + RT + ADT vs. niraparib alone vs. RT + ADT	Unselected	Maintenance of disease-free state
ASCLEPIuS NCT04194554	Phase I/II, single arm, open label	100	High risk locally advanced PCa (cN+)	Niraparib + AAP + leuprolide + RT	Unselected	DLT, biochemical failure (% of pts)
AMPLITUDE NCT04497844	Phase III, randomized	788	mHSPC	NIRAPARIB+AAP vs. PLACEBO+AAP	Selected	rPFS
ZZ-First (NCT04332744)	Phase II, randomized, open label	54	mHSPC	Enzalutamide vs. enzalutamide + talazoparib	Unselected	PSA-Complete Response