Study Comparing High-Intensity Focused Ultrasound and Robot-Assisted Surgery for Treatment of Localized Prostate Cancer in Men Over 40

What this Trial Is About

Researchers are studying the safety and effectiveness of the Sonablate system, a transrectal high-intensity focused ultrasound HIFU device, in treating localized prostate cancer. The study compares this treatment to robot-assisted laparoscopic radical prostatectomy RALP in terms of treatment outcomes, survival rates, postoperative PSA levels, cancer recurrence, and complications. The goal is to explore whether HIFU offers a safe and effective alternative treatment for localized prostate cancer. This observational study collects medical records and questionnaire data from patients treated with either HIFU or RALP at Renji Hospital. Patients are divided into two groups one receiving HIFU therapy and the other undergoing RALP surgery. No additional medication is given as part of the study. Data collection includes diagnostic tests and questionnaires at multiple time points before surgery, during surgery, and at 2, 6, 9, 12, 18, and 24 months after treatment. Participants will be monitored through medical history reviews, PSA level measurements, mp-MRI imaging, and quality of life assessments. Researchers will track postoperative complications, tumor control, biochemical recurrence, and survival rates over two years. Several validated questionnaires and diagnostic tools will be used to evaluate sexual function, urinary symptoms, and overall health status. The study follows patients both retrospectively and prospectively to better understand long-term outcomes and safety.

Clinical Study of HIFU for Localized Prostate Cancer