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 |
---|---|---|---|---|---|---|---|---|
NCT01682772/TOPARP-A | Olaparib | 2 | 50 | mCRPC after at least docetaxel | No | Tumor | Composite response rateb | All comers: 33% HRD: 88% |
NCT01682772/TOPARP-B | Olaparib | 2 | 98 | mCRPC after at least docetaxel | Bi-allelic deleterious HRD | Tumor | Composite response rateb Preplanned secondary endpoint: ORR | BRCA1/2: 83%, ORR: 52.4% PALB2: 57%, ORR: 33.3% ATM: 37%, ORR: 8.3% CDK12: 25%, ORR: 0% |
NCT02987543/PROfound | Olaparib versus NHT | 3 | 778 | mCRPC after at least 1 NHT | Bi- or mono-allelic somatic or germline deleterious HRD | Tumor | Radiographic PFS Preplanned secondary endpoint: OS | rPFS: BRCA/ATM: 7.4 months versus 3.6mo, HR = 0.34 (95% CI 0.25–0.47) General HRD: 5.8 months versus 3.5 months, HR = 0.49 (95% CI 0.38–0.63) OS: BRCA/ATM: 19.1 months versus 14.7 months HR = 0.69 (CI 95% 0.5–0.97) No-BRCA/ATM: 14.1 months versus 11.5 months HR = 0.96 (CI 95% 0.63–1.49) |
NCT03432897/BrUOG-337 | Olaparib | 2 | 13 | High-risk localized PC | Deleterious HRDa | Tumor or plasma | PSA response rate prior prostatectomy | Recruiting |
NCT03047135 | Olaparib | 2 | 50 | Castration Sensitive Biochemically Recurrent nmPC | No | Undescribed method | PSA response rate | Recruiting |
NCT03434158 /IMANOL | Olaparib as maintenance therapy after docetaxel | 2 | 27 | mCRPC after at least docetaxel | Deleterious HRDa | Undescribed method | Radiographic PFS | Recruiting |
NCT03012321/BRCAAway | Olaparib versus abiraterone versus abiraterone + olaparib | 2 | 70 | mCRPC, 1st line | No | Tumor | PFS | Recruiting |
NCT03263650 | Olaparib maintenance after cabazitaxel–carboplatin combination | 2 | 123 | Aggressive variant PC | No | Not performed | PFS | Ongoing, not recruiting |
NCT02854436/GALAHAD | Niraparib | 2 | 291 | mCRPC after at least 1 chemotherapy and 1 NHT | Bi-allelic HRD or germline pathogenic BRCA1/2 alterationb | Tumor or plasma | ORR | BRCA: 41% Non-BRCA: 9% |
NCT04288687 | Niraparib | 2 | 18 | mCRPC, platine sensitivity | Deleterious HRDa | Undescribed method | Radiographic PFS | Not yet recruiting |
NCT04037254 | ADT (24 months) + RT + niraparib (12 months) | 2 | 180 | High-risk localized PC | No | Not performed | Disease-free survival | Ongoing, not recruiting |
NCT04030559 | Niraparib for 3Â months | 2 | 30 | High-risk localized PC, prior prostatectomy | Bi- or mono-allelic deleterious HRD | Undescribed method | Pathologic response rate | Recruiting |
NCT02952534/TRITON-2 | Rucaparib | 2 | 193 | mCRPC after at least 1 chemotherapy and 1 NHT | Bi- or mono-allelic somatic or germline deleterious HRD | Tumor or plasma | ORR and PSA response rate (PRR) | sBRCA1/2: 43.9%, PRR: 50.7% gBRCA1/2: 42.9%, PRR: 61.4% ATM: 10.5%, PRR: 4.1% CDK12: 0%, PRR: 6.7% CHEK12: 11.1%, PRR: 16.7% |
NCT02975934/TRITON-3 | Rucaparib versus NHT or docetaxel | 3 | 400 | mCRPC, after 1 NHT, 0 chemotherapy | Deleterious BRCA1/2 or ATM alterationa | Undescribed method | Radiographic PFS | Recruiting |
NCT03413995/TRIUMPH | Rucaparib | 2 | 30 | mCSPC unfit/unwilling ADT | Germline HRD alterationb | Undescribed method | PSA response rate | Recruiting |
NCT03442556/PLATI-PARP | Rucaparib maintenance after docetaxel–carboplatin combination | 2 | 20 | mCRPC | Bi- or mono-allelic deleterious HRD | Tumor or plasma | Radiographic PFS | Recruiting |
NCT03533946/ROAR | Rucaparib | 2 | 32 | nmCSPC | Deleterious HRDa | Tumor or plasma | PSA response rate | Recruiting |
NCT03148795/TALAPRO-1 | Talazoparib | 2 | 100 | mCRPC after at least 1 chemotherapy and 1 NHT | Mono- or bi-allelic HRD (CDK12 excluded) | Tumor | ORR | BRCA: 50% ATM: 7% Other HRD: 0% |