A Safety and Pharmacokinetics Study of Niraparib plus androgen receptor-targeted therapy (apalutamide or abiraterone acetate and prednisone) in Men with Metastatic Castration-Resistant Prostate Cancer (protocol 64091742PCR1001)

Principal Investigator

Julie Graff

Study Purpose

The purpose of this study is to test the safety and tolerability of a combination of the study drugs niraparib and apalutamide in men with advanced prostate cancer. Niraparib is currently being studied for the treatment of ovarian, breast and advanced prostate cancer. Apalutamide is being studied for the treatment of advanced prostate cancer. This study tests different doses of the study drugs to see which dose combination is safer in people.

Medical Condition(s)

Prostate Cancer, Castration Resistant Prostate Cancer

Eligibility Criteria

1. Castration Resistant Prostate Cancer that is no longer responding to current therapy
2. Prior treatment with one of the following agents is required: Abiraterone acetate, enzalutamide, or apalutamide.
3. Prior treatment with at least 1 taxane-based chemotherapy (docetaxel and/or cabazitaxel) is required
4. A sample of tumor tissue is required, either previously collected or, if that is not available, you must be willing to have a biopsy to collect fresh tissue
5. Prior treatment with a PARP inhibitor is not allowed.

Age Range

18 - NA

Healthy Volunteers Needed


Duration of Participation

Up to 24 months

Minors Included



Clinical Trials Information Line: Phone 503-494-1080 or


Janssen Research & Development, LLC

Recruitment End


Compensation Provided


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