A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Status: Active

Description

The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years old at the time the informed consent is signed
  • Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
  • Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
  • Be eligible for treatment with physician's choice of comparator treatment (abiraterone acetate, enzalutamide or docetaxel)
  • Experienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy for castration-resistant disease
  • Have a deleterious mutation in a BRCA1/2 or ATM gene

Exclusion Criteria

  • Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
  • Prior treatment with any PARP inhibitor
  • Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
  • Symptomatic and/or untreated central nervous system metastases
  • Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Eddy Shih-Hsin Yang
Phone: 205-996-0780
Email: shyang@uabmc.edu

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Contact: Constance Lyn Murillo
Phone: 480-342-6056
Email: murillo.conny@mayo.edu

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Active
Name Not Available
San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: Active
Name Not Available

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: Enrolling by invitation
Contact: Michele Ann Besche
Phone: 410-328-8610
Email: mbesche@umm.edu

Massachusetts

Boston
Dana-Farber Harvard Cancer Center
Status: Active
Name Not Available

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: Active
Name Not Available

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Clovis Oncology

Trial IDs

Primary ID CO-338-063
Secondary IDs NCI-2017-01110, s16-02260
Clinicaltrials.gov ID NCT02975934