Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for men with metastatic hormone-sensitive prostate cancer, which means the cancer has spread but still responds to hormone therapy. The study is testing how well a combination of three treatments works together: darolutamide (a medicine that blocks cancer growth), hormone therapy to lower male hormones (called androgen deprivation therapy), and a chemotherapy drug called docetaxel. The goal is to see if this combination is safe and effective at controlling the cancer.

Men who might be eligible for this study are those aged 18 or older who have been diagnosed with this type of prostate cancer and whose doctors believe they need this specific combination treatment. Participants should be in good overall health with a life expectancy of more than one year and able to follow regular testing during the study. People with other serious health problems, allergies to the study medicines, or who are currently in another clinical trial would not be eligible. If you join, you can expect to receive these treatments under careful medical supervision to monitor how well the therapy works and to watch for any side effects. This study has not started recruiting yet, but it aims to find better ways to treat advanced prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Voluntarily signed informed consent form and able to understand and agree to comply with study requirements; Age ≥18； Male； Patients diagnosed with metastatic hormone-sensitive prostate cancer via CSCO guidelines, histopathology, etc.； Patients determined by treating physician to require darolutamide triplet therapy ECOG performance status score of 0-1 as evaluated by the Eastern Cooperative Oncology Group (ECOG) criteria； Life expectancy of over 1 year； Good compliance with regular serum PSA testing during treatment；
• Exclusion Criteria:
• • Presence of other malignancies within the past 2 years or currently; Severe cardiovascular/cerebrovascular disease within 6 months prior to study treatment initiation, including: severe/unstable angina, myocardial infarction, congestive heart failure \[NYHA Class III or worse\], stroke, or arrhythmia requiring medication; Allergy to any study drug or excipient; Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake/absorption; Underlying medical condition/alcohol or drug abuse/dependence that may interfere with drug administration, result in adverse events, or complicate outcome interpretation; Participation in another therapeutic clinical study; Deemed unsuitable for the study by the investigator.