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Placebo for Niraparib

DRUG3 trials

Sponsors

Janssen - Cilag International, Janssen Research & Development, LLC

Conditions

Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)Metastatic Castration-sensitive Prostate CancerMetastatic Prostate Cancer

Phase 3

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-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Active, not recruitingNCT04497844
Janssen Research & Development, LLCMetastatic Castration-sensitive Prostate Cancer
Start: 2020-09-23End: 2027-11-01Updated: 2026-03-20
A Phase 3 Randomized, Placebo-controlled, Double-blind 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-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Active, not recruitingCTIS2023-506365-64-00
Janssen - Cilag InternationalDeleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Start: 2020-10-16Target: 211Updated: 2026-01-13
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer
Active, not recruitingCTIS2023-503254-12-00
Janssen - Cilag InternationalMetastatic Prostate Cancer
Start: 2019-03-06Target: 235Updated: 2025-12-09

Related Papers

Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial.
2025-10-072 citations
Phase 3 AMPLITUDE trial: Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) for metastatic castration-sensitive prostate cancer (mCSPC) patients (pts) with alterations in homologous recombination repair (HRR) genes.
Journal of Clinical Oncology2025-06-0413 citations
Neoadjuvant fuzuloparib combined with abiraterone for localized high-risk prostate cancer (FAST-PC): A single-arm phase 2 study.
2025-03-074 citations
Genetic Landscape of Advanced Prostate Cancer Explored
Oncology Times2023-12-051 citations
AMPLITUDE: A study of niraparib in combination with abiraterone acetate plus prednisone (AAP) versus AAP for the treatment of patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).
Journal of Clinical Oncology2021-02-2044 citations