PROMIZE Phase III Study of Antibiotics Combined With Enzalutamide to Treat Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and anti-tumor effects of a combination of oral antibiotics with enzalutamide in patients who have metastatic castration-resistant prostate cancer mCRPC that has progressed after prior treatments including taxane chemotherapy and novel androgen axis therapies. This Phase III trial aims to explore whether adding antibiotics to enzalutamide can be safely administered and show signs of anti-cancer activity in this patient group. The study involves two phases. Phase I assesses the safety and tolerability of two sequential antibiotic combinationsamoxicillin plus metronidazole for 2 weeks followed by ciprofloxacin plus vancomycin for 2 weeksgiven in 4-week cycles alongside daily enzalutamide 160 mg. Enzalutamide treatment continues beyond antibiotic cycles until disease progression or intolerance. Phase II uses a two-stage design to evaluate anti-tumor activity of the safe dose and schedule identified in Phase I, enrolling up to 33 patients who have progressed after prior therapies. Participants will undergo regular monitoring including tumor assessments using RECIST and PCWG3 criteria, biochemical tests, and safety evaluations throughout the 28-day dose-limiting toxicity period and beyond. Study visits include blood tests, imaging, biopsies when feasible, and collection of biological samples for biomarker analysis. Researchers will measure safety, tolerability, response rates, progression-free survival, and other markers related to prostate cancer progression over the course of treatment and follow-up, with recruitment expected to complete within 24 months.

Combination Study of Antibiotics With Enzalutamide (PROMIZE)