IRB #

STUDY00017864

Title

TRITON3: A Multicenter, Randomized, Open-Label Phase 3 Study of Rucaparib versus Physician's Choice of Therapy for Patients with Metastatic Castration-Resistant Prostate Cancer Associated with Homologous Recombination Deficiency (protocol CO-338-063)

Principal Investigator

Julie Graff

Study Purpose

The purpose of this study is to find out how effective the study drug, rucaparib, is on advanced prostate cancer in men with DNA-Repair anomalies and to find out the side effects of the study drug. Rucaparib is currently FDA approved in advanced ovarian cancer, but not for prostate cancer.

Medical Condition(s)

Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

- Metastatic castration-resistant prostate cancer
- Previous therapy with at least one prior next-generation AR-targeted therapy for castration-resistant disease (such as: abiraterone acetate, enzalutamide, or investigational AR-targeted agent)
- Eligible for treatment with physician’s choice of comparator treatment, selected prior to randomization (abiraterone acetate, enzalutamide, or docetaxel)
- DNA-repair anomalies (to be tested as a part of the screening process)
- No prior treatments with a PARP inhibitor or a platinum containing chemotherapy regimen

Age Range

18 - 100

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

Clovis Oncology, Inc.

Recruitment End

12/01/2021

Compensation Provided

No


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