PROCEPT completes 280-patient WATER IV enrollment comparing Aquablation with prostate removal, wins IDE for second cancer trial

PROCEPT BioRobotics/HYDROS Robotic System (Aquablation)

PROCEPT finished enrolling 280 men in WATER IV RP, a randomized trial comparing Aquablation with radical prostatectomy for prostate cancer. The FDA also approved a second randomized study, WATER IV AS, against active surveillance in up to 333 men with lower-grade cancer. Both follow patients for ten years, tracking cancer control and urinary and sexual function.

• WATER IV RP: 280 patients, the only FDA randomized trial versus radical prostatectomy.
• Primary results expected at the AUA Annual Meeting in spring 2027.
• WATER IV AS: up to 333 patients, Grade Group 1-2 cancer, global.
• 10-year follow-up, with biopsy at 1 year and MRI at 3 years in the AS study.