PROCEPT BioRobotics Corp. (NASDAQ: PRCT) announced the completion of enrollment in its WATER IV study comparing Aquablation therapy to radical prostatectomy for prostate cancer treatment. The company also received FDA Investigational Device Exemption approval for a second randomized study.

The first WATER IV study enrolled 280 patients and represents the only FDA randomized trial comparing Aquablation therapy to radical prostatectomy. The company expects to present primary endpoint results at the American Urological Association Annual Meeting in spring 2027.

The second study, WATER IV AS, will enroll up to 333 patients globally and compare Aquablation therapy to active surveillance in men with Grade Group 1 and 2 prostate cancer. Active surveillance is commonly used for lower-risk prostate cancer patients to avoid quality-of-life impacts from radical treatment, though many patients eventually require surgery or radiation.

The WATER IV AS study aims to evaluate whether Aquablation therapy could provide an earlier treatment option before disease progression. Patients will be followed for ten years, with biopsy assessment at one year and MRI evaluation at three years.

"We are excited to complete enrollment in the first randomized WATER IV protocol, reflecting strong interest from physician investigators as well as patients in evaluating Aquablation as a new approach to prostate cancer treatment," said Larry Wood, President and Chief Executive Officer of PROCEPT BioRobotics.

Both studies will assess disease control and quality-of-life outcomes over ten years, including impacts on urinary, sexual, and overall function. The trials evaluate long-term experiences of men with prostate cancer receiving different treatment approaches.