AMPLITUDE trial: what clinicians have said so far
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)
- NCT04497844 ↗
- Active, not recruiting
- Janssen Research & Development, LLC
- Focused size, estimated: 1–150 verified statements
We haven't built an HCP commentary report on AMPLITUDE (niraparib in HRR-deficient metastatic castration-sensitive prostate cancer) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on AMPLITUDE so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Indexed so far | |
|---|---|
| 3 posts on X |
The trial
ClinicalTrials.gov- Official title
- 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)
- Phase
- Phase 3
- Status
- Active, not recruiting
- Conditions
- Prostatic Neoplasms
- Interventions
- Niraparib+ Abiraterone acetate fixed dose combination (FDC); Abiraterone acetate (AA); Prednisone; Placebo FDC; Placebo AA
- Arms
- Niraparib with Abiraterone Acetate plus Prednisone (AAP) · Experimental
- Placebo for Niraparib + AA FDC plus AA and prednisone (AAP) · Active comparator
- Enrollment
- 696
- Primary outcomes
- Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
- HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
- All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
- Sponsor
- Janssen Research & Development, LLC
- Start
- Sep 23, 2020
- Primary completion
- Jan 7, 2025
- Results posted
- Yes
- Registry record
- NCT04497844 · updated Nov 4, 2026
Publications
linked from the registry- Attard G, Agarwal N, Graff JN, Sandhu S, Efstathiou E, Ozguroglu M, Pereira de Santana Gomes AJ, Vianna K, Luo H, Gotto GT, Cheng HH, Kim W, Varela CR, Schaeffer D, Kramer K, Li S, Baron B, Shen F, Mundle SD, McCarthy SA, Olmos D, Chi KN, Rathkopf DE. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025 Dec;31(12):4109-4118. doi: 10.1038/s41591-025-03961-8. Epub 2025 Oct 7. PubMed 41057655