IRB #

STUDY00016539

Title

A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration Resistant Prostate Cancer and DNA - Repair Anomalies (protocol 64091742PCR2001)

Principal Investigator

Julie Graff

Study Purpose

The purpose of this study is to find out how effective the study drug, niraparib, on advanced prostate cancer in men with DNA-Repair anomalies and to find out the side effects of the study drug. Niraparib is currently being studied for the treatment of ovarian, breast and advanced prostate cancer.

Medical Condition(s)

Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

- 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
- Confirmed DNA-Repair Anomalies from the tested samples
- Castration Resistant Prostate Cancer that is no longer responding to current therapy
- Prior treatment with one of the following agents is required: Abiraterone acetate, enzalutamide, or apalutamide
- Prior treatment with at least 1 taxane-based chemotherapy is required
- No prior treatment with a PARP inhibitor

Age Range

18 - NA

Healthy Volunteers Needed

No

Duration of Participation

Up to 24 months.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Janssen Research & Development, LLC

Recruitment End

12/31/2024

Compensation Provided

No


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