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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT06151418
Eligibility Criteria:
Inclusion Criteria:
* Male with ≥ 1 diagnosis claim for prostate cancer
* Had documented secondary metastasis code on or after the initial prostate cancer diagnosis
* Had initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date
* ≥18 years old on index date
* Continuous enrollment for at least 365 days before index date
* Evidence to be castration-sensitive:
* No prior surgical castration any time prior to the index date or no medical castration with ≥8 weeks of continuous use within -90 to -365 days prior to the index date, OR
* Diagnosis of hormone sensitive malignancy status within 90 days before the index date
Exclusion Criteria:
* Evidence of castration-resistance prior to the index date
* Received other prostate cancer treatment including NHT, non-steroidal anti-androgen (NSAA), chemotherapy, immunotherapy, radium 223, lutetium Lu 177 vipivotide tetraxetan, ketoconazole, or PARP inhibitor prior to the index date
* Had diagnosis code indicating hormone resistance prior to the index date
* A rise in prostate-specific antigen from the nadir by ≥2 ng/mL after castration
* Had a prior history of other cancers (except non-melanoma skin cancer)
* Participation in a clinical trial during the 30 days before the index date
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06151418
Study Brief:
Protocol Section:
NCT06151418