Drug Use Investigation of Darolutamide in Addition to Standard Androgen Deprivation Therapy (ADT) and Docetaxel in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Condition: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Study Type: Observational
Clinical Trials Identifier NCT 8-digits: NCT06010914
Sponsor: Bayer
Phase:
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
Inclusion Criteria:
- 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 Criteria:
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to the local marketing authorization
- Previous treatment with darolutamide
View trial on ClinicalTrials.gov