Abiraterone acetate (AA)

DRUG2 trials

Sponsors

Janssen Research & Development, LLC

Conditions

Metastatic Castration-sensitive Prostate CancerProstatic Neoplasms

Phase 1

A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

Active, not recruitingNCT04577833

Janssen Research & Development, LLCProstatic Neoplasms

Start: 2020-11-13End: 2026-12-31Updated: 2026-03-13

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

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

Demonstrating Bioequivalence for Two Dose Strengths of Niraparib and Abiraterone Acetate Dual-Action Tablets Versus Single Agents: Utility of Clinical Study Data Supplemented with Modeling and Simulation

Clinical Pharmacokinetics2024-03-042 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