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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT06204302
Eligibility Criteria:
Inclusion Criteria:
* Men diagnosed with prostate cancer (≥1 claim for prostate cancer).
* Treatment with apalutamide, darolutamide or enzalutamide initiated for the first time in the nmPC stage during the patient identification period.
* Age ≥ 18 years at index date
* At least 6 months of continuous eligibility in medical and pharmacy benefits prior to the index date
* At least 6-months of continuous eligibility only in pharmacy benefits after the index date unless patient died before 6 months.
Exclusion Criteria:
* Patients with multiple ARIs recorded at index date
* Use of an ARI agent or abiraterone acetate prior to the index date
* Other cancer diagnosis (except prostate and skin cancer) during the 6-month baseline period
* Evidence of metastatic disease any time before or 30 days after index date.
* No claim with a diagnosis for hormone sensitive malignancy status (Z19.1) during the study period
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06204302
Study Brief:
Protocol Section:
NCT06204302