Plain-English translation of NCT06177015 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 study is testing a treatment strategy for men with advanced prostate cancer that has spread to other parts of the body. All participants will first receive 6 months of combination therapy including darolutamide (a hormone-blocking medication), chemotherapy, and hormone therapy. After that initial phase, if their cancer responds well, they'll be randomly assigned to either continue darolutamide indefinitely or use it intermittently—only restarting the medication when blood tests show the cancer is growing again.
Currently, doctors aren't sure whether men with this type of advanced cancer should stay on hormone-blocking medications continuously, or if taking breaks from treatment when cancer is well-controlled might work just as well while potentially reducing side effects and cost.
You likely qualify if…
You likely don't qualify if…
You would start with 6 months of daily medication (darolutamide) combined with hormone injections and chemotherapy, with regular blood tests and imaging scans to monitor how well the treatment is working. Once your cancer shows good response, you'd be randomly placed in one of two groups: one group continues the daily medication indefinitely, while the other group stops the medication and only restarts it if blood tests show cancer growth. Either way, you'll have blood tests every 3 months and imaging scans every 3 months to track your progress.
AI-generated summary from trial data · Jul 12, 2026 · Not medical advice
China
Phase
Large-scale testing
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Enrollment target
~200 participants
Started
December 2023
Primary completion
December 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
40 Years – 80 Years
Sex
Male only
Last updated on clinicaltrials.gov in December 2023.
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Central contact
Shangqian Wang
Urology Dpt, First Affiliated Hospital of Nanjing Medical University
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.