Plain-English translation of NCT06126731 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
The PROMIZE trial is testing whether using certain antibiotics alongside enzalutamide (a hormone therapy for prostate cancer) might help fight advanced prostate cancer that has become resistant to standard treatments. The idea is that these antibiotics may change your gut bacteria in a way that helps the hormone therapy work better. Researchers will first test whether this combination is safe and tolerable, then measure how well it actually works against the cancer.
Metastatic castration-resistant prostate cancer is a serious form of the disease that no longer responds to standard hormone treatments. This trial explores a new approach: using antibiotics to alter the gut microbiome in a way that might make the medication more effective, offering hope to patients with limited treatment options.
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You will take enzalutamide (160 mg) daily throughout the trial. During the first 8 weeks, you will also take rotating combinations of antibiotics: first amoxicillin plus metronidazole for 2 weeks, then ciprofloxacin plus vancomycin for 2 weeks, repeated for 2 full cycles. The trial has two stages—Phase I watches carefully for side effects in a small group, and Phase II tests how well the treatment works in a larger group. You will have regular clinic visits for blood tests, imaging scans, and possibly biopsies, and you'll be asked to provide blood, urine, stool, and rectal swab samples.
AI-generated summary from trial data · Jun 24, 2026 · Not medical advice
Switzerland
United Kingdom