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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT02489318
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of prostate adenocarcinoma as confirmed by the investigator
* Metastatic disease documented by greater than or equal to (\>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
* Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel \<=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
* Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (\<=) 6 months of ADT prior to randomization
* Allowed prior treatments for localized prostate cancer (all treatments must have been completed \>= 1 year prior to randomization) a) \<= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies
Exclusion Criteria:
* Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
* Known brain metastases
* Lymph nodes as only sites of metastases
* Visceral (ie, liver or lung) metastases as only sites of metastases
* Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
* Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
* History of seizures or medications known to lower seizure threshold
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02489318
Study Brief:
Protocol Section:
NCT02489318