Phase 2b Study Comparing Combination Therapy of Finasteride and Raloxifene Versus Finasteride Alone in Adult Men with Benign Prostatic Hyperplasia

What this Trial Is About

This research investigates new treatment strategies and biomarkers for benign prostatic hyperplasia BPH, a common condition causing urinary symptoms in older men. It focuses on why some patients do not respond to the usual drug finasteride, which targets the SRD5A2 enzyme important for prostate growth. The study explores how epigenetic changes and inflammation affect this enzyme and aims to find better therapies by combining finasteride with raloxifene, plus new ways to detect treatment resistance using non-invasive biomarkers. Participants will be randomly assigned to one of two groups one receiving finasteride plus a placebo, and the other receiving finasteride combined with raloxifene. Both medications are taken orally once daily. The trial is double-blinded and lasts 12 months, during which researchers will monitor treatment effects and evaluate if the methylation status of the SRD5A2 gene can predict response. The study will also assess prostate inflammation using imaging techniques. During the study, participants will be regularly assessed for clinical response, prostate symptoms, and erectile function using questionnaires. Blood tests and MRI scans will be used to measure biomarkers and inflammation. The main outcome is the clinical response after one year of treatment, along with safety monitoring for any side effects. This trial is conducted with adult men recommended finasteride for BPH and involves close follow-up for a full year.

New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia