Plain-English translation of NCT04916613 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether darolutamide, a newer type of prostate cancer medication, works better when combined with standard hormone therapy compared to hormone therapy alone. The study focuses on men with advanced prostate cancer that has spread to other parts of the body, particularly those who are frail, elderly, or have other health conditions that make stronger chemotherapy treatments too risky.
Many men with advanced prostate cancer are too frail or sick to tolerate the strongest available chemotherapy drugs. Researchers want to know if this medication, combined with standard hormone therapy, can help these patients live longer and control their cancer without causing serious side effects.
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If you join this trial, you will be randomly assigned to receive either hormone therapy plus the new medication (taken as a pill twice daily) or hormone therapy plus a placebo (a dummy pill). You'll visit the clinic regularly for blood tests and scans to monitor how the treatment is working and to check for side effects. The study continues until your cancer progresses or you and your doctor decide to stop, and you'll be followed for up to 10 years afterward to track your long-term health and any new treatments you receive.
AI-generated summary from trial data · Jun 24, 2026 · Not medical advice
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