TRITON3- Rucaparib vs. Physician Choice for Castration Resistant Prostate Cancer
Clinicaltrials.gov identifier:
NCT02975934
Treatment:
Prostate
Study Contact Information:
Questions about the study should be directed to Clovis Oncology Clinical Trial Navigation Service at: 1-855-262-3040 or by email
The study is open and recruiting at sites in CA, FL, GA, HI, MD, NE, NV, NJ, NY, NC, OH, TN, TX, VA.
A Study of Rucaparib Verses Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3)
About the Study
The purpose of Triton3 is to determine how patients with metastatic castration-resistant prostate cancer, and an inherited gene mutation or tumor genetic deficiency respond to treatment with the PARP inhibitor rucaparib (Rubraca) compared to treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
Type of Study
This is a randomized, open-label, 2-arm study. This study allows crossover.
- This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in. This is a 2:1 randomized study. This means that patients will have a slightly greater chance of being placed in the treatment group than the standard treatment group.
- The study has two arms. This means that patients in the study are placed in one of two different groups. One group will receive the PARP inhibitor rucaparib and the other group will receive one of three standard treatment options chosen by their oncologist.
- The study is open-label. All participating patients will know which group they have been assigned to.
- The study allows crossover. This means that patients who progress on the standard treatment arm will be given the opportunity to crossover into the rucaparib arm if they choose.
What Study Entails
- Patients with a known gene mutation in BRCA1, BRCA2 or ATM will be eligible.
- Patients will receive the oral PARP inhibitor, rucaparib (Rubraca) twice daily for 28 days.
- Patients will receive followup at 28 days.
- Patients will receive assessments every 12 weeks.
- Patients who receive clinical benefit from the drug may be considered for continued treatment even if their cancer has progressed.
- Patients receiving rucaparib whose cancer progresses will be taken off the study agent.
- Patients who progress on the standard treatment arm will be given the opportunity to crossover into the rucaparib arm if they choose.
Study Sites
United States
- Alabama
- Birmingham
- Arizona
- Phoenix
- Tucson
- California
- Beverly Hills
- Los Angeles
- San Bernardino
- San Diego
- San Francisco
- Santa Rosa
- Colorado
- Aurora
- Connecticut
- New Haven
- Florida
- Boca Raton
- Orlando
- Hawaii
- Honolulu
- Louisiana
- New Orleans
- Maryland
- Bethesda
- Baltimore
- Michigan
- Ann Arbor
- Detroit
- Minnesota
- Minneapolis
- Nebraska
- Omaha
- Nevada
- Las Vegas
- New Jersey
- New Brunswick
- New York
- Buffalo
- New York
- Poughkeepsie
- Rochester
- Syracuse
- North Carolina
- Chapel Hill
- Durham
- Ohio
- Cincinnati
- Middleburg Heights
- Oregon
- Portland
- Tennessee
- Nashville
- Texas
- Dallas
- Houston
- Round Rock
- Virginia
- Virginia Beach
- Washington
- Seattle
- Tacoma
International Sites
- Australia
- Belgium
- Canada
- Denmark
- France
- Germany
- Ireland
- Israel
- Italy
- Spain
- United Kingdom
Questions about the study should be directed to Clovis Oncology Clinical Trial Navigation Service at: 1-855-262-3040 or by email
Men with advanced prostate cancer who:
- have a known gene mutation in BRCA1, BRCA2 or ATM will be eligible.
- must have undergone surgical or medical castration (testosterone ≤ 50 ng/dL )
- have had their disease progress after receiving one of the following treatments for castration-resistant disease: "next-generation androgen receptor-targeted therapies": Enzalutamide, also known as Xtandi or Abiraterone, also known Zytiga).
Patients will be excluded if they have:
-
received prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
-
prior treatment with a PARP inhibitor, mitoxantrone, cyclophosphamide or platinum-based chemotherapy
-
any active second cancer diagnosis, with the exception of non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
- symptomatic and/or untreated central nervous system metastases