Table 2.
Phase II or III trials using PARP inhibitors in combination to treat prostate cancers
| 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 |
CRPC metastatic castration-resistant prostate cancer, mCSPC metastatic castration-sensitive prostate cancer, nmPC non-metastatic prostate cancer, NHT new hormonal therapy, HRR homologous recombination repair, HRD homologous repair deficiency, CTID clinical trial identification, PFS progression free survival, ORR objective response rate, OS overall survival, PSA response rate: decline of more than 50, AES adverse events. ATRi: ceralasertib: orally available inhibitor of ataxia telangiectasia and rad3 related (ATR) kinase
aMono- or bi-allelic status not specified