Procept BioRoboics | WATER IV | NCT06651632

About

Prostate cancer is the most commonly diagnosed cancer in American men, with approximately 300,000 new cases each year. Localized prostate cancer is confined to the prostate and is potentially curable with treatment. The standard surgical treatment, radical prostatectomy (removal of the prostate), is highly effective but carries well-known risks of urinary incontinence and erectile dysfunction that can significantly impact quality of life. Aquablation therapy is a newer robotic procedure using a high-pressure water jet guided by ultrasound to remove prostate tissue, with the potential for better functional outcomes.

Purpose

This randomized trial compares Aquablation therapy—a robotic, ultrasound-guided waterjet procedure—to radical prostatectomy in men with low-to-high-risk localized prostate cancer. The dual primary endpoints are rates of urinary incontinence (pad use) and erectile dysfunction at 6 months. Participants will be followed for up to 10 years to assess long-term cancer control and quality of life. This study will determine whether Aquablation provides equivalent cancer control with better functional outcomes than traditional surgery.

Eligibility

• Men age ≥45 with biopsy-confirmed Grade Group 1–3 prostate cancer who are candidates for radical prostatectomy
• Clinical stage ≤T2c and PSA ≤20 ng/mL
• Prostate volume ≥25 mL
• No prior or current treatment for prostate cancer (surgery, radiation, hormone therapy, or chemotherapy)
• No evidence of lymph node involvement, bone metastasis, or extracapsular tumor extension

Benefits

If you qualify for the study, all study-related medical care and treatment will be provided to you at no cost. You may receive a stipend for your participation in the study.

Send us a message if you are interested in participating in a study.