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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT03124433
Eligibility Criteria:
Inclusion Criteria:
* histologically diagnosed primary adenocarcinoma of the prostate gland
* non-metastatic D'Amico intermediate to high risk patients undergoing radical prostatectomy as primary definitive therapy
* no known hypersensitivity to the study drug
* able to swallow study drug as whole tablets
Exclusion Criteria:
* presence of small cell, neuroendocrine or ductal differentiation at needle biopsy
* individuals with prior pelvic irradiation therapy for any form of pelvic malignancy
* patients with psychiatric conditions requiring anti-psychotic therapy, or preventing the provision of informed consent
* renal impairment with serum creatinine more than twice the upper limit of normal
* Other prior malignancy less than or equal to 5 years prior to recruitment
* ECOG performance status 2 or poorer
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT03124433
Study Brief:
Protocol Section:
NCT03124433