Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT02975934
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
* 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02975934
Study Brief:
Protocol Section:
NCT02975934