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

Running, not enrolling · Phase 2

Conditions studied: Prostatic Neoplasms, Castration-Resistant

In brief

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).

Key facts

Study ID

NCT03431350

Run by

Janssen Research & Development, LLC

People needed

136

Starts

2018-03-02

Expected to finish

2026-12-31

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
• Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: non-muscle invasive bladder cancer; skin cancer (non-melanoma or melanoma); breast cancer; malignancy that is considered cured with minimal risk of recurrence
• Active infection requiring systemic therapy
• Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients
• Combination 3:
• Symptomatic brain metastases
• Prior disease progression during combination treatment with AA and poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity

Where it is running

• Urological Associates of Southern Arizona, P.C. — Tucson, Arizona, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Mayo Clinic - Division Of Hematology/oncology — Jacksonville, Florida, United States
• First Urology, PSC — Jeffersonville, Indiana, United States
• Chesapeake Urology Research Associates — Towson, Maryland, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• New York Oncology Hematology — Albany, New York, United States
• Memorial Sloan Kettering Cancer Center 1 — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• MUSC-Hollings Cancer Center — Charleston, South Carolina, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Associates — Nashville, Tennessee, United States
• Houston Metro Urology — Houston, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• Urology of Virginia, PLCC — Virginia Beach, Virginia, United States
• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States
• OLV Ziekenhuis Aalst — Aalst, Belgium
• ZNA Middelheim — Antwerp, Belgium
• ULB Hôpital Erasme — Brussels, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Az Groeninge — Kortrijk, Belgium
• Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman — Liège, Belgium

Full record on ClinicalTrials.gov

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