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This study compares the drug Rucaparib with the physician's choice of therapy (Abiraterone acetate, Enzalutamide or Docetaxel) in men with metastatic castration-resistant prostate cancer who carry a deleterious mutation in the BRCA1/2 or ATM gene. It enrolled patients over 18 whose disease had progressed after a prior next-generation androgen receptor-targeted therapy. The study was carried out in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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 * 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