Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

NCT03431350 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).

Interventions

  • DRUG Prednisone 5 mg
  • DRUG Niraparib 200 mg
  • DRUG Cetrelimab 240 mg
  • DRUG Cetrelimab 480 mg
  • DRUG Abiraterone acetate 1000 mg

Study Locations (20)

New York

  • New York Oncology Hematology — Albany
  • Memorial Sloan Kettering Cancer Center — Harrison
  • Memorial Sloan Kettering Cancer Center — New York

Pennsylvania

  • Thomas Jefferson University — Philadelphia
  • University of Pittsburgh Medical Center (UPMC) — Pittsburgh

South Carolina

  • MUSC-Hollings Cancer Center — Charleston
  • Carolina Urologic Research Center — Myrtle Beach

Texas

  • Houston Metro Urology — Houston
  • The University of Texas MD Anderson Cancer Center — Houston

Arizona

  • Urological Associates of Southern Arizona, P.C. — Tucson

Colorado

  • The Urology Center of Colorado — Denver

Florida

  • Mayo Clinic - Division Of Hematology/oncology — Jacksonville

Indiana

  • First Urology, PSC — Jeffersonville

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2018-03-02
Est. Completion 2025-12-31
Phase Phase 2

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03431350

The ClinicalTrials.gov registry entry for NCT03431350 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Prostatic Neoplasms, Castration-Resistant appearing as the primary indexed condition, and to 5 interventions — of which Prednisone 5 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03431350 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Pennsylvania, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03431350 about?

NCT03431350 is a clinical study titled "A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer". The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Com...

What is the current status of trial NCT03431350?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2018-03-02. Estimated completion is 2025-12-31.

What conditions does trial NCT03431350 study?

This clinical trial studies the following conditions: Prostatic Neoplasms, Castration-Resistant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03431350?

The interventions under investigation include: Prednisone 5 mg (DRUG), Niraparib 200 mg (DRUG), Cetrelimab 240 mg (DRUG), Cetrelimab 480 mg (DRUG), Abiraterone acetate 1000 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03431350?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03431350 being conducted?

This trial has 20 study locations across Arizona, Colorado, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial