Table 2 Phase II or III trials using PARP inhibitors in combination to treat prostate cancers
From: Prostate cancer and PARP inhibitors: progress and challenges
CTID | Treatment | Phase | No. patients or estimated enrollment | Disease status | Mandatory HRR status for inclusion | Determination method for HRD | Primary endpoints | Results |
|---|---|---|---|---|---|---|---|---|
NCT01972217 | Abiraterone ± olaparib | 2 | 142 | mCRPC after docetaxel, no prior NHT | No | Plasma or blood or tumor | Radiographic PFS | 13.8 months (combination) versus 8.2 months (control), P = 0.034, HR = 0.65 (CI 95% 0.44–0.97) |
NCT03732820/PROpel | Abiraterone ± olaparib | 3 | 720 | mCRPC, 1st line | No | Tumor | Radiographic PFS | Ongoing, not recruiting |
NCT02484404 | Olaparib + durvalumab | 2 | 17 | mCRPC after 1 NHT | No | Not performed | Clinical efficacy | PSA response rate: 53%, Radiographic response: 44% Radiographic PFS: 16.1 months |
NCT02861573/KEYNOTE-365 cohort A | Olaparib + pembrolizumab | 2 | 41 | mCRPC after at least docetaxel | No | Not performed | PSA response rate, safety | PSA response rate: 13% |
NCT03834519/KEYLINK-010 | Olaparib + pembrolizumab vs NHT | 3 | 780 | mCRPC after CT and 1 NHT | No | Not performed | OS, radiographic PFS | Recruiting |
NCT03810105 | Olaparib + durvalumab | 2 | 32 | Castration Sensitive Biochemically Recurrent nmPC | Bi- or mono-allelic deleterious HRD | Undescribed method | Number of undetectable PSA | Recruiting |
NCT04336943 | Olaparib + durvalumab | 2 | 30 | Castration Sensitive Biochemically Recurrent nmPC | Deleterious HRD, bi-allelic CDK12 alteration, MSIa | Undescribed method | Number of undetectable PSA | Recruiting |
NCT03787680 /TRAP | Olaparib + ATRi (AZD6738) | 2 | 45 | mCRPC after docetaxel or 1 NHT | Cohort 1: no Cohort 2:a HRD | Tumor or blood | ORR in DNA repair proficient patients | Recruiting |
NCT03516812 | Olaparib + testosterone | 2 | 30 | mCRPC after 1 NHT, no chemotherapy | 50% witha deleterious HRD, 50% with competent HRR | Tumor or blood | PSA decrease, AES | Recruiting |
NCT02893917 | Olaparib ± cediranib | 2 | 90 | mCRPC after 2 lines of treatment | No | Not performed | Radiographic PSA | Ongoing, not recruiting |
NCT03748641/MAGNITUDE | Abiraterone ± niraparib | 3 | 1000 | mCRPC, 1st line | No | Tumor | Radiographic PFS | Recruiting |
NCT04497844/AMPLITUDE | ADT + abiraterone ± niraparib | 3 | 788 | mCSPC | No | Tumor | Radiographic PFS | Recruiting |
NCT03431350 | Niraparib + cetrelimab or niraparib + abiraterone | 1–2 | 148 | mCRPC after 1 or 2 NHT | No | Not performed | ORR and AES | Recruiting |
NCT04455750/CASPAR | Enzalutamide ± rucaparib | 3 | 1002 | mCRPC, 1st line | No | Tumor | Radiographic PFS and OS | Not yet recruiting |
NCT03338790/CheckMate 9KD | Nivolumab + rucaparib/enzalutamide/docetaxel | 2 | 330 | mCRPC | No | Not performed | ORR and PSA response rate | Ongoing, not recruiting |
NCT03395197 (TALAPRO-2) | Enzalutamide ± talazoparib | 3 | 1037 | mCRPC, 1st line | No | Not performed | Radiographic PFS | Recruiting |
NCT04332744/ZZ-first | ADT + enzalutamide ± talazoparib | 2 | 54 | mCSPC high volume | No |  | PSA complete response rate | Recruiting |