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



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:January 2017
End Date:April 2022
Contact:Clovis Oncology Clinical Trial Navigation Service
Email:clovistrials@emergingmed.com
Phone:1-855-262-3040 (USA)

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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

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.


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

- 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
We found this trial at
42
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