Last updated on July 2019

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer


Brief description of study

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate and prednisone (AA-P) compared to AA-P plus placebo.

Detailed Study Description

This study will assess efficacy and safety of niraparib in combination with AA-P for the treatment of participants with metastatic prostate cancer. Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone and selectively inhibits the enzyme 17-hydroxylase/C17,20-lyase (CYP17), which is found in the testes and adrenals, as well as in prostate tissues and tumors. In participants with metastatic prostate cancer, DNA-repair gene defects (DRD) are identified in approximately 15 percent (%) to 20% of tumors. The study will consist of 4 phases: a prescreening phase for biomarker evaluation only, a screening phase, a double-blind treatment phase, and a follow up phase. During the prescreening phase participants will be evaluated for DRD and then will be assigned to one of the 2 cohorts based on their biomarker status. Treatment will be administered daily and is planned to be continuous until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. Efficacy, pharmacokinetics, biomarkers, participants reported outcomes and safety will be assessed. The total duration of study will be approximately up to 73 months.

Clinical Study Identifier: NCT03748641

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San Bernardino Urological Associates

San Bernardino, CA United States
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Urology Associates of Denver

Englewood, CO United States
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VA Connecticut Healthcare

West Haven, CT United States
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Bay Pines VA Healthcare System

Bay Pines, FL United States
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Advanced Urology Institute

Daytona Beach, FL United States
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University of Florida

Jacksonville, FL United States
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Norton Healthcare

Louisville, KY United States
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Rcca Md, Llc

Bethesda, MD United States
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Massachusetts General

Boston, MA United States
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Delaware Valley Urology, LLC

Mount Laurel, NJ United States
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Upstate Cancer Center

Syracuse, NY United States
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Lancaster Urology

Lancaster, PA United States
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VA Pittsburgh

Pittsburgh, PA United States
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Carolina Urologic Research Center

Myrtle Beach, SC United States
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Utah Cancer Specialists

Salt Lake City, UT United States
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Salem VA Medical Center

Salem, VA United States
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Urology of Virginia, PLCC

Virginia Beach, VA United States
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Hospital Aleman

Buenos Aires, Argentina
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Centro de Urologia (CDU)

Ciudad Automoma Buenos Aires, Argentina
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CEMIC Saavedra

Ciudad Autonoma Buenos Aires, Argentina
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Sanatorio Parque

Rosario, Argentina
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ARS M dica

San Salvador de Jujuy, Argentina
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Macquarie University

Macquarie University, Australia
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Cabrini Health

Malvern, Australia
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ZNA Middelheim

Antwerpen, Belgium
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Multiscan s.r.o.

Pardubice, Czechia
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Centre Jean Perrin

Clermont Ferrand, France
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HIA Begin

Saint Mande, France
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National Cancer Center

Goyang-Si, Korea, Republic of
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Severance Hospital

Seoul, Korea, Republic of
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Asan Medical Center

Seoul, Korea, Republic of
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Gangnam Severance Hospital

Seoul, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Seoul St. Mary's Hospital

Seoul, Korea, Republic of
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Ajou University Hospital

Suwon, Korea, Republic of
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Hospital Pulau Pinang

George Town, Malaysia
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Hospital Likas

Kota Kinabalu, Malaysia
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Hospital Kuala Lumpur

Kuala Lumpur, Malaysia
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iBiomed Research Unit

Aguascalientes, Mexico
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NKI-AVL, Amsterdam

Amsterdam, Netherlands
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Erasmus MC

Rotterdam, Netherlands
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Recruitment Status: Open


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