Table 3.
Ongoing PARPi trials in prostate cancer.
| Study Name (NCT Number) | Phase | Patient Population | Study Design | Primary Endpoint |
|---|---|---|---|---|
| Monotherapy | ||||
| TALAPRO-1 (NCT03148795) | Phase II | DDR-mutated mCRPC progressed on a taxane or androgen-receptor signaling inhibitor | talazoparib | Objective Response Rate |
| ROAR (NCT03533946) | Phase II | DDR-mutated mCRPC | rucaparib | PSA decline ≥50% rate |
| Galahad (NCT02854436) | Phase II | DDR-mutated mCRPC who progressed on an androgen-receptor signaling inhibitor and taxane-chemotherapy | niraparib | Objective response rate |
| TRITON3 (NCT02975934) | Phase III | germline or somatic BRCA1, BRCA2, or ATM mutations and mCRPC who previously progressed on an androgen-receptor signaling inhibitor and who have not received chemotherapy | rucaparib versus abiraterone, enzalutamide, or docetaxel | Progression-free survival |
| PROfound (NCT02987543) | Phase III | mCRPC who progressed on an androgen-receptor signaling inhibitor | olaparib versus enzalutamide or abiraterone in patients with DDR-mutated | Progression-free survival |
| Combination Therapy | ||||
| PROpel (NCT03732820) | Phase III | mCRPC who have not received taxane-chemotherapy or an androgen-receptor signaling inhibitor | abiraterone and olaparib versus abiraterone and placebo | Progression-free survival |
| BRCAaway (NCT03012321) | Phase II | DDR-mutated mCRPC | Abiraterone versus olaparib and abiraterone versus olaparib | Progression-free survival |
| TALAPRO-2 (NCT03395197) | Phase III | asymptomatic or mildly symptomatic mCRPC, without brain metastases, never having received taxane-chemotherapy or an androgen-receptor signaling inhibitor | enzalutamide and talazoparib versus enzalutamide and placebo (prestratify based on DDR mutaton status) | Progression-free survival |
| MAGNITUDE (NCT03748641) | Phase III | treatment naïve mCRPC | niraparib and abiraterone versus abiraterone and placebo | Progression-free survival |
| KEYLINK-010 (NCT03834519) | Phase III | mCRPC progressed on an androgen-receptor signaling inhibitor | pembrolizumab and olaparib versus enzalutamide or abiraterone | Progression-free survival and Overall survival |
| NCT03317392 | Phase I/Phase II | mCRPC with any number of bone metastases | olaparib and radium-223 | Progression-free survival |
| NCT02893917 | Phase II | mCRPC who progressed on one prior line of therapy | olaparib versus olaparib and cediranib | Progression-free survival |
| NCT03572478 | Phase I/Phase IIa | mCRPC who progressed on an androgen-receptor signaling inhibitor | rucaparib and nivolumab | Dose limiting toxicity |
| NCT03516812 | Phase II | mCRPC who progressed on an androgen-receptor signaling inhibitor | olaparib and testosterone injection | PSA decline ≥50% rate |
| NCT03810105 | Phase II | DDR-mutated mCRPC | olaparib and durvalumab | Number of patients with undetectable PSA |