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A phase 3 trial of Abiraterone acetate, Niraparib and Prednisone in prostate cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC) is a phase 3 interventional study registered as NCT04497844 by Janssen Research & Development, LLC, with 696 participants enrolled, started 2020-09-23 and due to reach its primary completion in 2025-01-07. Interventions recorded: Niraparib+ Abiraterone acetate fixed dose combination (FDC), Abiraterone acetate (AA), Prednisone, Placebo FDC and Placebo AA. Results have been posted on the registry.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
696 enrolled.
95% CI 22.11 to 41.17; Figures from the ClinicalTrials.gov results section (first posted 2026-01-22), not from a publication · Median and the upper limit of the 95% confidence interval (CI) were not estimable due to an insufficient number of participants with events.
Source95% CI 25.59 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-01-22), not from a publication · Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events.
Source95% CI 25.82 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-01-22), not from a publication · Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigatorprimary | BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone | 196 | 25.99 months | 0.515 (0.37 to 0.717) | <0.0001 | link |
| BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone | 191 | Median and the upper limit of the 95% confidence interval (CI) were not estimable due to an insufficient number of participants with events. | ||||
| HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigatorprimary | HRR Effector Subgroup: Placebo With Abiraterone Acetate Plus Prednisone | 226 | 27.56 months | 0.571 (0.421 to 0.774) | 0.0003 | link |
| HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone | 230 | Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events. | ||||
| All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigatorprimary | Placebo With Abiraterone Acetate Plus Prednisone | 348 | 29.54 months | 0.625 (0.49 to 0.799) | 0.0001 | link |
| Niraparib With Abiraterone Acetate Plus Prednisone | 348 | Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events. |
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