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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT07086651
Eligibility Criteria:
Inclusion Criteria:
* Male patients diagnosed with metastatic prostate cancer
* Initiated apalutamide or enzalutamide for the first-line treatment of metastatic castration-sensitive prostate cancer (mCSPC). Initiation date of first treatment defines the index date.
* Index date on or after 1 January 2020
* Evidence of androgen deprivation therapy (ADT) use between 90 days prior to the index date and 6 months following the index date
* Age ≥18 years on the index date -≥6 months of clinical activity following the index date, unless the patient died
Exclusion Criteria:
* Evidence of castration-resistance prior to the index date
* Received chemotherapy, androgen receptor pathway inhibitor, radiopharmaceuticals, immunotherapy, PARP inhibitor, or estrogens prior to the index date
* Evidence of ADT use between 1 year and 91 days prior to the index date
* Had a prior history of other cancers
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07086651
Study Brief:
Protocol Section:
NCT07086651