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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT03641560
Eligibility Criteria:
Inclusion Criteria:
* Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
* Subject with established diagnosis of metastatic castration-resistant prostate carcinoma.
* Subject is being newly initiated on Xtandi treatment (Enzalutamide).
* Subject has an estimated life expectancy of ≥ 6 months.
* Subject agrees not to participate in another interventional study while participating in the present study.
Exclusion Criteria:
* Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.
* Subject participating or planning to participate in any interventional drug trial during the course of this trial.
* Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.
* Subject has any condition which makes the subject unsuitable for study participation.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03641560
Study Brief:
Protocol Section:
NCT03641560