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



  • 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