Condition: Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Low-volume Metastasis

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT06661122

Sponsor: Bayer

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of prostate.
• Patients have low-volume of metastatic disease documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Low-volume metastasis criteria is defined as "not" meeting the high-volume criteria of the CHAARTED trial; high-volume meet the presence of visceral metastases, or four or more bone lesions including at least one outside the vertebral column or pelvis.
• Documented diagnosis of mHSPC.
• Patients on triplet regimen previously decided by the investigator irrespective of enrollment in the study.
• Start ADT within 6 months before or at the index date.
• Signed informed consent: If an eligible patient is deceased at the time of study initiation, informed consent from the legally representative(s) of the patient is required. Opt-out consent is acceptable in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects only when it is difficult to obtain signed informed consent from the patient or their legal representative.

Exclusion Criteria:

• Patients treated with docetaxel before darolutamide start.
• Participation in an investigational program with interventions outside of routine clinical practice.
• Contra-indications to darolutamide, docetaxel and ADT according to the local marketing authorization.
• Participation in the PASS of darolutamide in patients with mHSPC (DADOX [NCT06010914]).

View trial on ClinicalTrials.gov