Table 1. Ongoing trials of PARPi combination therapies with NHTs in PC.
| PARPi | Trial, NCT No. | Study phase/design | Population | Combined agent & grouping | Primary outcomes | |
|---|---|---|---|---|---|---|
| Olaparib | PROact, NCT05167175 | Phase 2/Single Group Assignment | mHSPC (HRR+) | Olaparib+AA | rPFS | |
| NU_16U05/NCT03012321 | Phase 2/RCT | mCRPC | AA vs. Olaparib vs. Olaparib+AA | Objective PFS | ||
| D081SC00001Sub/NCT05171816 | Phase 3/RCT | mCRPC | Olaparib+AA vs. Placebo+AA | rPFS | ||
| PROpel/NCT03732820 | Phase 3/RCT | mCRPC | Olaparib+AA vs. Placebo+AA | rPFS | ||
| Rucaparib | CASPAR/NCT04455750 | Phase 3/RCT | mCRPC (HRR+) | Rucaparib+Enzalutamide vs. Placebo+Enzalutamide | rPFS; OS | |
| Niraparib | ASCLEPIuS/NCT04194554 | Phase 1, 2/Single Group Assignment | PC | AA+Leuprolide+100 mg/200 mg Niraparib but held for 5 days (+/– 2 days) prior to RT, during SBRT, and 5 days (+/– 2 days) after last fraction of SBRT AA+Leuprolide+200 mg Niraparib without breaks during SBRT until completion of 6 cycles | DLT; Proportion of patients experiencing biochemical failure | |
| AMPLITUDE/NCT04497844 | Phase 3/RCT | mHSPC (HRR+) | Niraparib+AA vs. Placebo+AA | rPFS | ||
| MAGNITUDE/NCT03748641 | Phase 3/RCT | mCRPC | Treatment: | rPFS | ||
| Phase RCT: Niraparib+AA vs. Placebo+AA; | ||||||
| Phase OLE: all receive Niraparib+AA | ||||||
| Cohort 1: Participants with mCRPC and HRR Gene Alteration; | ||||||
| Cohort 2: Participants with mCRPC and No HRR Gene Alteration; | ||||||
| Cohort 3 (Open-label): Participants with mCRPC | ||||||
| Talazoparib | ZZ-First/NCT04332744 | Phase 2/RCT | mHSPC | Talazoparib+Enzalutamide+ADT vs. Enzalutamide+ADT | PSA-CR | |
| TALAPRO-2/NCT03395197 | Phase 3/RCT | mCRPC | Talazoparib+Enzalutamide vs. Placebo+Ezalutamide | Confirm the dose of Talazoparib (part 1); rPFS (part 2) | ||
| TALAPRO-3/NCT04821622 | Phase 3/RCT | mHSPC (DDR mutated) | Talazoparib+Enzalutamide vs. Placebo+Enzalutamide | rPFS | ||
mHSPC: metastatic hormone-sensitive PC, HRR: homologous recombination repair, rPFS: radiographic progression-free survival, mCRPC: metastatic castration-resistant prostate cancer, RCT: randomized controlled trial, OS: overall survival, PC: prostate cancer, DLT: dose limiting toxicities, ADT: androgen deprivation therapy, PSA-CR: prostate specific antigen complete response, DDR: DNA damage response.