Study of Darolutamide Combined With Hormone Therapy for Men in Germany With Advanced Prostate Cancer That Has Spread and Still Responds to Hormone Treatment

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