Randomized Trial Comparing Focal HIFU Treatment to Radical Prostatectomy for Intermediate Risk Prostate Cancer in Men Aged 50 to 75

What this Trial Is About

This research aims to compare the cost-effectiveness of focal high-intensity focused ultrasound F-HIFU treatment versus radical prostatectomy RP in men with favorable intermediate risk localized prostate cancer. The study focuses on patients with non-treated prostate cancer characterized by specific Gleason scores and tumor visibility on MRI, evaluating both treatments from a healthcare system perspective. It is a randomized, pragmatic clinical trial conducted across multiple centers, aiming to provide insights into cancer control and side effect profiles such as urinary, sexual, and digestive outcomes. Participants will be randomly assigned to receive either F-HIFU using the Focal-Oneae device under local or general anesthesia or undergo a radical prostatectomy performed via open, laparoscopic, or robot-assisted surgery under general anesthesia. Randomization is stratified by center and initially equal but later adjusted to a 21 ratio favoring F-HIFU. Treatment is followed by regular monitoring up to 48 months, with data collection enhanced using national health databases to assess costs, mortality, and cancer control without additional patient visits. During the study, men will undergo assessments including urinary and sexual function evaluations, quality of life questionnaires, and survival monitoring at multiple timepoints up to 48 months. The primary outcome focuses on the cost-utility ratio at 24 months, with secondary outcomes including survival rates, preserved life costs, and treatment-related quality of life. Participants are closely followed through clinical visits and data linkage, ensuring comprehensive evaluation of both treatment approaches over time.

Cost-utility of Focal HIFU vs Prostatectomy