A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Trial ID or NCT#
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.
TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency
- - Be 18 years old at the time the informed consent form 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) - Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease - Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency
- - 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, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy - 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 rucaparib
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