Table 3.

Current Clinical Trials of PARP1 Inhibitors in Prostate Cancer

Study #	Phase/Design	Disease State	Agent	Prior Treatment	Primary Outcome
NCT01972217	II, double blind, placebo controlled, RCT	Metastatic CRPC	Abiraterone + Olaparib vs. Abiraterone + placebo	Docetaxel	Radiologic PFS
NCT02324998	I, open label RCT	Localized intermediate/high risk prostate cancer	Neoadjuvant Olaparib vs. neoadjuvant Olaparib + Degarelix	none	Degree of PARP inhibition
NCT01078662	II, open label non-randomized, non-controlled	Advanced ovarian, breast, prostate, pancreatic, advanced tumors w/BRCA1 and/or BRCA2 mutations	Olaparib	All ok but previous PARPi	Tumor response rate
NCT02500901	I, open label, non-randomized, non-controlled	Metastatic prostate cancer	Enzalutamide + Niraparib	All ok but prior PARPi, ezalutamide or other next generation AR targeted therapy	Maximum tolerated dose
NCT01576172	II, open label RCT	Metastatic CRPC	Abiraterone + prednisone + Veliparib vs. Abiraterone + prednisone	All ok	PSA response rate
NCT02952534	II, open label	Metastatic CRPC w/HR deficiency (BRCA1/2, ATM, or molecular evidence of HR deficiency)	Rucaparib	Abiraterone and/or Enzalutamide and 1 prior taxane based chemotherapy. No prior PARPi, mitoxantrone, cyclophosphomide, platinum-based chemotherapy.	ORR and PSA response
NCT02975934	III, open label, RCT	Metastatic CRPC w/HR deficiency (BRCA1/2, ATM)	Rucaparib vs. standard therapy (enzalutamide, abiraterone + prednisone, or docetaxel)	1 prior next generation androgen receptor targeted therapy. No prior PARPi	rPFS