Plain-English translation of NCT05348876 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.
This trial is testing a medication called darolutamide to see how safe it is when combined with standard hormone therapy (called androgen deprivation therapy) in men with a type of prostate cancer called non-metastatic castration-resistant prostate cancer, or nmCRPC. This is cancer that continues to grow even when testosterone levels are lowered through medication or surgery. The medication works by blocking cancer cells from using male hormones to fuel their growth.
Researchers have already tested this medication successfully in other countries, but they want to make sure it works safely for Indian patients specifically, since the earlier studies didn't include Indian participants.
You likely qualify if…
You likely don't qualify if…
You would take the medication darolutamide by mouth, along with your regular hormone therapy, for as long as your doctor thinks it is helping and you are tolerating it well. Throughout the study, your doctor will monitor you with regular blood tests and check-ups to watch for any side effects or changes in your PSA levels and overall health. The study involves about 50 men in India, and researchers will carefully track any medical problems that occur to make sure the treatment is safe.
AI-generated summary from trial data · Jul 8, 2026 · Not medical advice
India
Male only
Last updated on clinicaltrials.gov in July 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Bayer Clinical Trials Contact
Bayer
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.