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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: Active Phase 3 study of Castration Resistant Prostatic Cancer, sponsored by Janssen Research & Development.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; (2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progressio

Conditions Studied

Castration Resistant Prostatic Cancer

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

FieldValue
Enrollment Target 765 participants
Start Date 2019-01-25
Est. Completion 2027-02-27
Phase Phase 3
Janssen Research & Development

593 total trials

What the registry record for NCT03748641 still lists

NCT03748641 is an interventional study that assigns participants to a tested intervention. The registered 765 participants enrollment target is mid-sized for trials with a published cap, above the 162-participant average among 5 other Castration Resistant Prostatic Cancer trials with a reported enrollment target (372% higher).

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 names 20 study sites across 11 states, led by 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.

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Related registry views

Source: ClinicalTrials.gov NCT03748641, the US trial registry maintained by the National Library of Medicine. NCT03748641 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.