Table 4.
Active clinical trials on PARP-i in prostate cancer.
| PARP-i | Clinical Trial | Phase | Patient Population | Somatic Mutations/Germline PVs | Treatment Arm(s) |
|---|---|---|---|---|---|
| Olaparib |
NCT03434158 (IMANOL) |
2 | mCRPC | BRCA1, BRCA2, ATM, FANC, CHEK2, MLH1, MSH2, MSH6, PMS2, PALB2, RAD51C, MRE11 | Olaparib |
| NCT03012321 | 2 | mCRPC |
BRCA1, BRCA2, ATM Other DDR mutations |
Abiraterone alone OR Olaparib alone OR Abiraterone + Olaparib |
|
| NCT03516812 | 2 | CRPC | MMR deficiency, HR deficiency |
Olaparib + Testosterone | |
| NCT03317392 | 1–2 | mCRPC | Not required | Olaparib + Radium 233 | |
|
NCT03834519 (KEYLYNK-010) |
3 | mCRPC | Not available | Pembrolizumab + Olaparib Vs Abiraterone OR Enzalutamide |
|
| NCT03432897 | 2 | Locally advanced Prostate cancer |
BRCA1, BRCA 2, ATM, CHEK1, CHEK2, FANCONI ANEMIA (FANCL), HDAC2, PALB2, BARD1, BRIP1, CDK12, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L |
Olaparib alone | |
| NCT03810105 | 2 | Castration sensitive AND biochemically recurrent prostate cancer | BRCA1, BRCA2, ATM, CHEK2, FANCA, RAD51C, RAD51D, PALB2, BRIP1, BARD1, or CDK12 | Olaparib + Durvalumab | |
| Niraparib | NCT02854436 | 2 | mCRPC | BRCA1, BRCA2, or other DDR alteration | Niraparib alone |
| NCT04037254 | 2 | High-risk prostate cancer | Not required | Niraparib + ADT | |
| NCT04030559 | 2 | High-risk localized prostate cancer | DDR deficiency | Neoadjuvant Niraparib | |
| Rucaparib | NCT03442556 | 2 | mCRPC | DDR deficiency | Rucaparib |
|
NCT02975934 (TRITON3) |
3 | mCRPC | BRCA1, BRCA2 or ATM | Rucaparib OR Docetaxel OR Abiraterone OR Enzalutamide |
|
|
NCT03413995 (TRIUMPH) |
2 | mHSPC | BRCA1, BRCA2, ATM, CHEK2, NBN, RAD50, RAD51C, RAD51D, PALB2, MRE11, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, FANCM | Rucaparib alone | |
| NCT03533946 | 2 | Non-metastatic prostate cancer | ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, ERCC3, FAM175A, FANCA, FANCL, GEN1, HDAC2, MLH1, MRE11, NBN, PALB2, PPP2R2A, RAD51, RAD54L | Rucaparib alone | |
| Talazoparib |
NCT03395197 (TALAPRO-2) |
3 | mCRPC | DDR assessment required | Talazoparib + Enzalutamide |
| NCT03330405 | 2 | mCRPC | ATM, BRCA1 and BRCA2 | Talazoparib + Avelumab | |
| NCT04332744 | 2 | mHSPC | Not required | Talazoparib + Enzalutamide |
mCRPC: metastatic castration-resistant prostate cancer; mHSPC: metastatic hormone-sensitive prostate cancer; Prostate cancer: prostate cancer; MMR: mismatch repair; HR: homologous recombination; DDR: DNA damage repair; ADT: androgen-deprivation therapy.