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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT02663193
Eligibility Criteria:
Inclusion Criteria:
* Male 18 years of age or older
* Have confirmed metastatic adenocarcinoma of the prostate
* Are starting treatment with enzalutamide or abiraterone acetate (with prednisone) for metastatic castration-resistant prostate cancer (mCRPC) at the full recommended dose per each drug's respective prescribing information (PI)
* Have an Eastern Cooperative Oncology Group Performance Status score of 0 or 1
* Sign written informed consent
Exclusion Criteria:
* Have a pre-existing central nervous system (CNS) condition (including, but not limited to, history of stroke or dementia) that, in the participating physician's judgment, would preclude participation in the study
* Have known mental illness including, but not limited to, major depressive disorder, general anxiety disorder, or bipolar disorder that, in the participating physician's opinion, could significantly confound the patient-reported outcome (PRO) assessments
* Have a history of or ongoing seizure disorder
* Have severe hepatic impairment (Child-Pugh Class C)
* Have an active infection (example, human immunodeficiency virus \[HIV\], viral hepatitis) or other medical condition that would contraindicate the use of prednisone/prednisolone (systemic glucocorticoid)
* Have known alcohol or other substance abuse disorder
* Are routinely taking medication-including, but not limited to, over-the-counter medications, supplements, medical marijuana or prescription pain medication-that is known to cause mental confusion or sedation or are using any of the medications
* Are routinely taking systemic glucocorticoids (example, prednisone, prednisolone, dexamethasone) at a dosage higher than the equivalent of prednisone 10 milligram (mg) daily
* Are currently using or have previously used chemotherapy for any cancer including mCRPC
* Are concurrently using any first-generation androgen-receptor blocker (example, bicalutamide, flutamide, nilutamide) for mCRPC
* Have previously taken enzalutamide or abiraterone acetate with prednisone
* Are not capable of completing tests using a computerized system or completing a participant survey
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02663193
Study Brief:
Protocol Section:
NCT02663193