A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
Phase 3
Active, not recruiting
NCT03748641
| Condition | Castration-Resistant Prostatic Cancer |
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| Phase | Phase 3 |
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| Sponsor | Janssen Research & Development, LLC |
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| Status | Active, not recruiting |
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| Enrollment | 765 participants |
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| Interventions | Niraparib, Abiraterone Acetate, Prednisone, New Formulation of Niraparib and Abiraterone Acetate (AA) |
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| Start date | Jan 25, 2019 |
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| Completion date | Oct 8, 2021 |
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| Results posted | Oct 4, 2023 |
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Summary
The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
Up to 32 months · Months
| Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 16.46 Months |
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| Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 13.70 Months |
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| p-value | 0.0217 |
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| Hazard Ratio (HR) | 0.729 (95% CI 0.556–0.956) |
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Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
Up to 32 months · Months
| Cohort 1 BRCA Subgroup: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 16.56 Months |
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| Cohort 1 BRCA Subgroup: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 10.87 Months |
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| p-value | 0.0014 |
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| Hazard Ratio (HR) | 0.533 (95% CI 0.361–0.789) |
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Open in BENITIONS
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