Feasibility Study of Adding Metformin and Turmeric to Intermittent Androgen Deprivation Therapy for Men With Biochemically Progressive Castration Sensitive Prostate Cancer

What this Trial Is About

Researchers are evaluating the feasibility of adding a nutritional regimen combining metformin and turmeric to the current standard treatment, intermittent Androgen Deprivation Therapy iADT, for patients with castration sensitive biochemical progressive prostate cancer. This Phase 1 study aims to assess the study populations feasibility and enrollment, and to evaluate the time to PSA relapse with this nutritional intervention alongside iADT. The study also seeks to explore the roles of metabolic syndrome, microbiome, and genetic profiles in patient care. Participants will begin metformin at 500 mg twice daily by mouth with meals, gradually increasing to 1,000 mg twice daily over several weeks. After two weeks of metformin titration, turmeric supplementation will start at 1,500 mg daily with meals, with a possible temporary dose reduction to 1,000 mg for gastrointestinal discomfort. Those currently taking metformin may continue their current dose or titrate as described. If turmeric-related symptoms persist, participants may be asked to stop the study treatment. All subjects will receive a dietary consultation and continue their iADT as standard care. During the study, participants will keep a pill diary and provide blood and stool samples for biomarker and microbiome analysis. Quality of life will be assessed using validated questionnaires including FACT-P and AMS. Standard laboratory tests will be performed as part of routine care. The primary outcomes include feasibility of recruitment over 12 months and time to PSA relapse up to 27 months. Secondary outcomes include quality of life measures over the same period. Total participation may last up to 27 months with ongoing monitoring and data collection.

A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy