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NCT03748641 · ClinicalTrials.gov registry record · Phase 3
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
A Phase 3 study of Castration Resistant Prostatic Cancer, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 765
- Enrollment target
- 20
- Study locations
NCT03748641 is a Phase 3 study of Castration Resistant Prostatic Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 765 participants, above the 162-participant average among 5 other Castration Resistant Prostatic Cancer trials with a reported enrollment target (372% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT03748641, a Phase 3 study of Castration Resistant Prostatic Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 765 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Prednisone
- DRUG Abiraterone Acetate
- DRUG Niraparib
- DRUG New Formulation of Niraparib and Abiraterone Acetate (AA)
Study Locations (20)
California
- Kaiser Permanente - Riverside
- San Bernardino Urological Associates - San Bernardino
- University of California San Francisco - San Francisco
- Sansum Clinic Pharm - Santa Barbara
Florida
- Bay Pines VA Healthcare System - Bay Pines
- Advanced Urology Institute - Daytona Beach
- University of Florida Health Jacksonville - Jacksonville
- Mayo Clinic - Division Of Hematology/oncology - Jacksonville
Arizona
- Mayo Clinic Arizona - Phoenix
- Urological Associates of Southern Arizona, P.C. - Tucson
Colorado
- The Urology Center of Colorado - Denver
- Colorado Clinical Research - Lakewood
Indiana
- Fort Wayne Medical Oncology and Hematology - Fort Wayne
- First Urology - Jeffersonville
Alabama
- Urology Centers Of Alabama - Homewood
Arkansas
- Arkansas Urology - Little Rock
Connecticut
- VA Connecticut Healthcare - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 765 participants |
| Start Date | 2019-01-25 |
| Est. Completion | 2027-02-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03748641
The ClinicalTrials.gov registry entry for NCT03748641 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 765 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 162-participant average among 5 other Castration Resistant Prostatic Cancer trials with a reported enrollment target (372% 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 Castration Resistant Prostatic Cancer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03748641 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03748641 about?
NCT03748641 is a clinical study titled "A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer". 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.
What is the current status of trial NCT03748641?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 765 participants. The study started on 2019-01-25. Estimated completion is 2027-02-27.
What conditions does trial NCT03748641 study?
This clinical trial studies the following conditions: Castration Resistant Prostatic Cancer.
What interventions are being tested in trial NCT03748641?
The interventions under investigation include: Placebo (DRUG), Prednisone (DRUG), Abiraterone Acetate (DRUG), Niraparib (DRUG), New Formulation of Niraparib and Abiraterone Acetate (AA) (DRUG).
Who is sponsoring clinical trial NCT03748641?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03748641 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.