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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT06334120
Eligibility Criteria:
Inclusion Criteria:
* Male aged ≥19 years
* Patients with high risk nmCPRC
* Castrate level of serum testosterone (\< 1.7 nmol/l \[50 ng/dL\])
* PSA doubling time \< 10 months
* Patients with mHSPC
* histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography (CT), or magnetic resonance imaging (MRI).
* be candidates for androgen-deprivation therapy with/without docetaxel.
* Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice
* Written informed consent from subject or legal representative; assent from subject when appropriate
Exclusion Criteria:
* Patients participating in an investigational program with interventions outside of routine clinical practice
* Participants with contraindication according to the locally approved prescribing information
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
19 Years
Study:
NCT06334120
Study Brief:
Protocol Section:
NCT06334120