Table 1.
Ongoing clinical trials assessing the role of PARPi in mCRPC.
| Clinical trial | Phase | Study drug | Strategy | Primary endpoint |
|---|---|---|---|---|
| NCT02861573 | I | Olaparib | Pembrolizumab + olaparib in postdocetaxel setting | RR (PSA50) |
| NCT03874884 | I | Olaparib | Olaparib + 177Lu-PSMA in mCRPC | DLTs, MTD, RP2D |
| NCT03205176 | I | Olaparib | Olaparib ± AZD5153 (BRD4/BET bromodomain inhibitor) in mCRPC | DLT |
| NCT02484404 | I/II | Olaparib | Olaparib ± ceridanib ± MEDI4736 (anti-PD-1) in mCRPC | RP2D, AE |
| NCT03317392 | I/II | Olaparib | Ra223 ± olaparib in mCRPC patients with bone metastases | MTD, rPFS |
| NCT03787680 | II | Olaparib | Olaparib + ATR inhibitor (AZD6738) in second-line setting | RR |
| NCT03012321 | II | Olaparib | Olaparib ± abiraterone/prednisone in first-line setting | PFS |
| NCT03434158 | II | Olaparib | Olaparib for patients who are responding after docetaxel chemotherapy | rPFS |
| NCT03263650 | II | Olaparib | Olaparib for patients who are responding after cabazitaxel plus carboplatin | PFS |
| NCT03516812 | II | Olaparib | Olaparib + testosterone enanthate in postabiraterone/enzalutamide setting | RR (PSA50) |
| NCT02893917 | II | Olaparib | Olaparib ± cediranib in second-line setting | rPFS |
| NCT03732820 | III | Olaparib | Abiraterone/prednisone ± olaparib in first-line setting | rPFS |
| NCT03834519 | III | Olaparib | Olaparib plus pembrolizumab versus abiraterone acetate or enzalutamide after chemotherapy and ARSi | OS and PFS |
| NCT03076203 | I | Niraparib | Niraparib + radium-223 | MTD |
| NCT03431350 | I/II | Niraparib | Niraparib + abiraterone/prednisone or JNJ-63723283 in post-ARSi setting | AE, ORR |
| NCT02854436 | II | Niraparib | Niraparib in postdocetaxel and post-ARSi settings | ORR |
| NCT03748641 | III | Niraparib | Abiraterone/prednisone ± niraparib in first-line setting | rPFS |
| NCT04179396 | I | Rucaparib | Rucaparib + abiraterone or enzalutamide in mCRPC | PK, AE |
| NCT03840200 | I | Rucaparib | Rucaparib + ipatasertib in mCRPC after ARSi | AE, DLTs, PSA response |
| NCT04253262 | I/II | Rucaparib | Rucaparib + copanlisib (PI3K inhibitor) in mCRPC progressing after ARSi | MTD, ORR |
| NCT03840200 | I/II | Rucaparib | Rucaparib + ipatasertib after ARSi | AE, DLT, RR (PSA) |
| NCT03572478 | I/II | Rucaparib | Rucaparib vs. rucaparib + nivolumab vs. nivolumab | DLT |
| NCT02952534 | II | Rucaparib | Rucaparib in postdocetaxel and post-ARSi settings | ORR |
| NCT03338790 | II | Rucaparib | Nivolumab + rucaparib or docetaxel or enzalutamide | ORR |
| NCT03442556 | II | Rucaparib | Rucaparib for patients who are responding after docetaxel plus carboplatin | rPFS |
| NCT02975934 | III | Rucaparib | Rucaparib vs. abiraterone/enzalutamide/docetaxel in second-line setting | rPFS |
| NCT04019327 | I/II | Talazoparib | Talazoparib + temozolomide in mCRPC without DNA damage repair mutation after at least one ARSi | AE, ORR |
| NCT04052204 | I/II | Talazoparib | Talazoparib + avelumab + bempegaldesleukin in mCRPC | DLT, ORR |
| NCT03330405 | II | Talazoparib | Avelumab plus talazoparib in advanced solid tumors | DLT, ORR |
| NCT03148795 | II | Talazoparib | Talazoparib in postdocetaxel and postabiraterone/enzalutamide settings | ORR |
| NCT03395197 | III | Talazoparib | Enzalutamide ± talazaparib in first-line setting | rPFS |
| NCT04182516 | I | NMS-03305293 | NMS-03305293 (PARP inhibitor) in mCRPC | First cycle DLTs |
RR: response rate; PSA50: decline in PSA level ≥50% than baseline; MTD: maximum tolerated dose; rPFS: radiological progression-free survival; PFS: progression-free survival; OS: overall survival; AE: adverse events; ORR: objective response rate; DLT: dose-limiting toxicities; MTD: maximum tolerated dose; RP2D: recommended phase II dose; and PK: pharmacokinetic.