DAROlutamide DoUBlet Therapy in Daily Practice (DARO-DUB) - Real-world Evaluation of Patients With Metastatic Hormone-sensitive Prostate Cancer Treated With Darolutamide Plus ADT in Germany

What this Trial Is About

The trial investigates metastatic hormone-sensitive prostate cancer (mHSPC), a condition where cancer cells in the prostate have spread but still respond to hormone treatment. Researchers aim to evaluate how well combining darolutamide, a newer androgen-receptor inhibitor, with hormone therapy (androgen-deprivation therapy or ADT) works for men in Germany with this advanced prostate cancer. The main focus is on how many men achieve very low or undetectable prostate-specific antigen (PSA) levels in their blood after 12 months of treatment, which indicates cancer activity. Participants receive darolutamide plus ADT treatment, with darolutamide dosed at 2x300 mg twice daily alongside hormone therapy. Data collection aligns with routine care visits and includes information about the patients’ background, prostate cancer details, and treatments. The study lasts for five years, during which researchers monitor treatment duration, timing, dosage changes, and any additional anti-cancer therapies or side effects. Men involved in the study have their health and prostate cancer status tracked through routine medical visits, including baseline, treatment, follow-up, and end-of-study observations. Researchers collect data on PSA levels at 3, 6, 9, and 12 months, as well as monitor survival over 60 months. They also record patient demographics, clinical characteristics, testosterone values, medication changes, and adverse events to understand how well the treatment performs and is tolerated over time.

How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany