Procept BioRobotics | WATER IV | NCT06651632

About

Prostate cancer is the most commonly diagnosed cancer in American men, with about 300,000 new cases each year, and roughly 70% are found while still confined to the prostate. Many men with early, lower-risk disease are monitored with active surveillance, which involves regular PSA tests, MRI scans, and biopsies. However, some of these cancers eventually progress, and many men later need radical treatment such as surgery or radiation, which carry risks like urinary incontinence and erectile dysfunction. Better ways to treat early disease while preserving quality of life are needed.

Purpose

This randomized trial compares Aquablation therapy, a robotic, ultrasound-guided waterjet procedure that removes prostate tissue, with active surveillance in men with localized prostate cancer (Grade Group 1 or 2). Up to 333 participants will be randomized 2:1 to Aquablation or active surveillance. The primary goal is to see whether Aquablation increases the number of men free of Grade Group 2 or higher cancer on biopsy at 1 year. Participants are followed for 10 years, and additional cancer treatments are allowed and tracked.

Eligibility

• Men age ≥45 with biopsy-confirmed Grade Group 1 cancer with an MRI-visible lesion or Grade Group 2 prostate cancer who are candidates for active surveillance
• First prostate cancer diagnosis within the past 18 months
• Clinical stage ≤T2c, PSA ≤15 ng/mL, and prostate volume ≥25 mL
• No prior or current treatment for prostate cancer (surgery, radiation, hormone therapy, or chemotherapy)
• No evidence of lymph node or bone spread, tumor growth outside the prostate, or seminal vesicle invasion

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.