Table 2.
Ongoing clinical trials with the combination of PARP inhibitors and NHTs in PC.
| Drug | Subjects | Study Registration No./Title | Study Design | Study Phase | Treatment & Grouping | Primary Outcomes | Study Progress |
|---|---|---|---|---|---|---|---|
| Olaparib | mHSPC (carry deleterious germline or HRR mutations) |
NCT05167175/ PROact |
Single Group Assignment | Phase II | Olaparib+AA | rPFS | Recruiting |
| mCRPC |
NCT01972217/ D081DC00008 |
RCT | Phase II | Olaparib+AA vs Placebo+AA | rPFS; Percentage of Patients with Progression Events or Death | Active, not recruiting | |
| mCRPC |
NCT03012321/ NU_16U05 |
RCT | Phase II | AA vs. Olaparib vs. Olaparib+AA | Objective PFS | Recruiting | |
| mCRPC |
NCT05171816/ D081SC00001Sub |
RCT | Phase III | Olaparib + AA vs. Placebo+ AA | rPFS | Active, not recruiting | |
| mCRPC |
NCT03732820/ PROpel |
RCT | Phase III | Olaparib+AA vs. Placebo+AA | rPFS | Active, not recruiting | |
| Niraparib | PC |
NCT04194554/ ASCLEPIuS |
Single Group Assignment | Phase I, II | AA+Leuprolide+100 mg/200mg Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT AA+Leuprolide+200 mg Niraparib without breaks during SBRT until completion of 6 cycles |
DLT; Proportion of patients experiencing biochemical failure |
Recruiting |
| deleterious germline or somatic HRR gene-mutated mHSPC |
NCT04497844/ AMPLITUDE |
RCT | Phase III | Niraparib+AA vs. Placebo+ AA | rPFS | Recruiting | |
| mCRPC |
NCT04577833/ CR108783 |
RCT | Phase I | Treatment: Niraparib Formulation 1: A; Niraparib Formulation 2: B; Niraparib Formulation 3: C; Niraparib Formulation 4: D; Cohort: AA+Treatment ABD; AA+Treatment ADB; AA+Treatment CBD; AA+Treatment CDB |
Cmax,ss; AUC(0-24h),ss; Ratio of Individual Cmax,ss Values; Ratio of individual AUC (0-24h),ss Values |
Active, not recruiting | |
| mCRPC |
NCT03748641/ MAGNITUDE |
RCT | Phase III | Treatment: Phase RCT: Niraparib+AA vs. Placebo+ AA; Phase OLE:all receive Niraparib+AA Cohort 1: Participants with mCRPC and HRR Gene Alteration; Cohort 2: Participants with mCRPC and No HRR Gene Alteration; Cohort 3 (Open-label): Participants with mCRPC |
rPFS | Active, not recruiting | |
| Rucaparib | CRPC and mPA and phase IV/IVA/IVB PC |
NCT04455750/ CASPAR |
RCT | Phase III | Rucaparib+Enzalutamide vs. Placebo+Enzalutamide | rPFS;OS | Recruiting |
| mCRPC |
NCT04179396/ RAMP |
Non-Randomized, Parallel Assignment |
Phase Ib | Rucaparib+Enzalutamide vs. Rucaparib+AA | PK; treatment-related AEs/SAEs | Active, not recruiting | |
| Talazoparib | HSPC |
NCT04734730/ 20476 |
Single Group Assignment | Phase II | Talazoparib+AA+ADT | PSA nadir<0.2 | Recruiting |
| mHSPC |
NCT04332744/ ZZ-First |
RCT | Phase II | Talazoparib+Enzalutamide+ADT vs. Enzalutamide+ADT | PSA-CR | Recruiting | |
| DDR-deficient mHSPC |
NCT04821622/ TALAPRO-3 |
RCT | Phase III | Talazoparib + Enzalutamide vs. Placebo + Enzalutamide | rPFS | Recruiting | |
| mCRPC |
NCT03395197/ TALAPRO-2 |
RCT | Phase III | Talazoparib+Enzalutamide vs. Placebo+Ezalutamide | Confirm the dose of Talazoparib (part 1); rPFS(part 2) | Active, not recruiting |
RCT: Randomized controlled trial; OLE, Open label extension; PC, Prostate cancer; mCRPC, Metastatic castration resistant prostate cancer; mHSPC, Metastatic hormone-sensitive prostate cancer; AA, Abiraterone Acetate plus Prednisone; rPFS, Radiographic progression-free survival; OS, Overall survival; ADT, Androgen deprivation therapy; SBRT, Stereotactic body radiotherapy; DLT, Dose Limiting toxicities; MTD, Maximum Tolerated dose; RP2D, Recommended Phase 2 Dose; PPSA, Prostate specific antigen; CR, Complete response.