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:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT02918968
Eligibility Criteria:
Inclusion Criteria:
* Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small-cell histology.
* Subject on continuous ADT with Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or bilateral orchiectomy.
* Serum testosterone level below the target level at screening visit.
* Subject with asymptomatic or mildly symptomatic prostate cancer.
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject has progression of the disease as defined by rising PSA levels or progressive soft tissue or bony disease during CAB therapy in combination of bicalutamide and ADT.
* A sexually active male subject and the subject's female partner who is of childbearing potential must use 2 acceptable birth control methods from screening to 3 months after the last dose of the study drug.
* Subject must agree not to donate sperm from screening to 3 months after the last dose of the study drug.
Exclusion Criteria:
* Subject with severe concurrent diseases, infections, or complications.
* Subject with confirmed or suspected brain metastasis or active leptomeningeal metastasis.
* Subject with a history of malignant tumor other than prostate cancer in the past 5 years.
* Subject hypersensitive to the ingredients of enzalutamide capsules or flutamide tablets.
* Subject with a history of convulsive attack, or prone to convulsive attack.
* Subject with liver disorder such as viral hepatitis and hepatic cirrhosis, or subject with Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) at screening visit higher than the upper limit of normal.
* Subject received treatment for prostate cancer with cytocidal chemotherapy that includes anti androgenic agents other than bicalutamide, abiraterone, or estramustine.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT02918968
Study Brief:
Protocol Section:
NCT02918968