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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07395804
Eligibility Criteria:
Inclusion Criteria:
* Male patients aged ≥ 18 years
* Diagnosis of mHSPC with histological or cytological evidence for adenocarcinoma of prostate
* Metastatic disease by conventional or new generation imaging
* Physician decision to initiate treatment with Darolutamide plus ADT was made as per investigtor's routine treatment practice prior to enrollment in the study
* Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws)
Exclusion Criteria:
* Darolutamide treatment started more than 30 days prior to study enrollment
* ADT treatment started more than 12 weeks before the start of treatment with Darolutamide plus ADT
* Hypersensitivity to Darolutamide or any other excipient
* Other prior systemic hormonal or anti-cancer treatment for mHSPC
* Participation in an investigational program for prostate cancer with interventions outside of routine clinical practice
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07395804
Study Brief:
Protocol Section:
NCT07395804