Active Surveillance Plus Using High-Intensity Focused Ultrasound to Treat Localized Intermediate-Risk Prostate Cancer A Study on Tumor Control and Reduced Side Effects Compared to Radical Treatment

What this Trial Is About

Researchers are evaluating the use of high-intensity focused ultrasound HIFU as a focal treatment combined with active surveillance in men with localized intermediate-risk prostate cancer. This approach aims to reduce the need for radical treatment of the entire prostate, which often causes side effects like erectile dysfunction and urinary incontinence. The study compares outcomes with a historical group of patients who underwent active surveillance alone, seeking to determine if focal therapy can safely control cancer progression while minimizing side effects. Participants with MRI-visible tumors and specific intermediate-risk prostate cancer will receive focal HIFU treatment targeting the main tumor. This is a prospective, single-arm study where all enrolled patients receive the same focal therapy and are then followed closely. The study will compare results to a historical control group treated with active surveillance from 2009 to 2017. The goal is to see if focal treatment reduces the need for radical therapy and maintains good cancer control and quality of life. During the trial, participants will undergo regular MRI scans, biopsies, and clinical evaluations over 1 to 10 years. Researchers will monitor tumor status, need for additional treatments, survival outcomes, and side effects related to erectile function and continence. Patient-reported quality of life will also be assessed. The study plans to include 245 men aged 55 to 80 with specific cancer risk profiles and will follow them long-term to evaluate tumor control, functional results, and overall survival.

Active Surveillance Plus (AS+): High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer