A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Registration Number
- NCT06010914
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria:<br><br> - Men over the age of 18 years<br><br> - Histologically or cytologically confirmed adenocarcinoma prostate cancer<br><br> - Metastatic disease confirmed either by a positive bone scan, or for soft tissue or<br> visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed<br> tomography (CT) or magnetic resonance imaging (MRI) scan<br><br> - Patients diagnosed with mHSPC by the investigator under routine clinical practice,<br> and must be judged appropriate for/decided to be treated with darolutamide plus ADT<br> and docetaxel therapy by the investigator under routine clinical practice<br><br> - ADT (GnRH agonist/antagonist or orchiectomy) before or simultaneous treatment with<br> darolutamide<br><br> - Signed informed consent<br><br>Exclusion Criteria:<br><br> - Participation in an investigational program with interventions outside of routine<br> clinical practice<br><br> - Contraindications according to the local marketing authorization<br><br> - Previous treatment with darolutamide
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with cardiac treatment-emergent adverse events (TEAEs);Outcomes of cardiac TEAEs;Dose modifications due to cardiac TEAEs
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs);Patient demographics/characteristics;Descriptive summary of dosing patterns of darolutamide;Outcomes of AEs;Dose modifications due to AEs