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NCT04497844 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Metastatic Castration-Sensitive Prostate Cancer, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 696
- Enrollment target
- 20
- Study locations
NCT04497844 is a Phase 3 study of Metastatic Castration-Sensitive Prostate Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 696 participants, above the 424-participant average among 5 other Metastatic Castration-Sensitive Prostate Cancer trials with a reported enrollment target (64% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT04497844, a Phase 3 study of Metastatic Castration-Sensitive Prostate Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 696 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG Niraparib
- DRUG Abiraterone acetate (AA)
- DRUG Placebo for Niraparib
Study Locations (20)
California
- Greater Los Angeles VA Healthcare System - Los Angeles
- University of California Irvine Medical Center Chao Family Comprehensive Cancer Center - Orange
- San Bernardino Urological Associates - San Bernardino
- University of San Francisco California - San Francisco
Florida
- Advanced Urology Institute - Daytona Beach
- Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center - Fort Lauderdale
- University of Florida Health Jacksonville - Jacksonville
- Cancer Specialists of North Florida - Jacksonville
Colorado
- Rocky Mountain Cancer Centers - Colorado Springs
- AdventHealth Medical Group Urology of Denver - Denver
- Colorado Clinical Research - Lakewood
Arizona
- Mayo Clinic Arizona - Phoenix
- Urological Associates of Southern Arizona, P.C. - Tucson
Indiana
- Urology of Indiana - Greenwood
- First Urology - Jeffersonville
Maryland
- Baltimore VA Medical Center - Baltimore
- Maryland Oncology Hematology, PA - Columbia
Alabama
- Urology Centers Of Alabama - Homewood
Connecticut
- Eastern Connecticut Hematology & Oncology Assoc. - Norwich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 696 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2027-11-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04497844
The ClinicalTrials.gov registry entry for NCT04497844 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 696 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 424-participant average among 5 other Metastatic Castration-Sensitive Prostate Cancer trials with a reported enrollment target (64% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Castration-Sensitive Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Prednisone is the first listed.
NCT04497844 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04497844 about?
NCT04497844 is a clinical study titled "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)". The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Can...
What is the current status of trial NCT04497844?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 696 participants. The study started on 2020-09-23. Estimated completion is 2027-11-01.
What conditions does trial NCT04497844 study?
This clinical trial studies the following conditions: Metastatic Castration-Sensitive Prostate Cancer.
What interventions are being tested in trial NCT04497844?
The interventions under investigation include: Prednisone (DRUG), Niraparib (DRUG), Abiraterone acetate (AA) (DRUG), Placebo for Niraparib (DRUG).
Who is sponsoring clinical trial NCT04497844?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04497844 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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