Status:
ACTIVE_NOT_RECRUITING
A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer
Lead Sponsor:
Bayer
Conditions:
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Eligibility:
MALE
18+ years
Brief Summary
This is an observational study in which only data are collected from participants receiving their usual treatment. In this study, data will be collected and studied from men with metastatic hormone-s...
Eligibility Criteria
Inclusion
- Men over the age of 18 years
- Histologically or cytologically confirmed adenocarcinoma prostate cancer
- Metastatic disease confirmed either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan
- Patients diagnosed with mHSPC by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with darolutamide plus ADT and docetaxel therapy by the investigator under routine clinical practice
- ADT (GnRH agonist/antagonist or orchiectomy) before or simultaneous treatment with darolutamide
- Signed informed consent
Exclusion
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to the local marketing authorization
- Previous treatment with darolutamide
Key Trial Info
Start Date :
October 9 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06010914
Start Date
October 9 2023
End Date
January 31 2027
Last Update
September 17 2025
Active Locations (1)
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1
Many Locations
Multiple Locations, Japan