The WATER IV PCa trial will compare Aquablation to radical prostatectomy. Procept expects the study to enroll up to 280 men with Grade Group 1 to 3 localized prostate cancer. It takes place across 50 centers, following the patients for 10 years. The study has a co-primary endpoint based on morbidity evaluated at the six-month follow-up. Longer-term follow-up focuses on both the reduction in treatment-related harm and oncologic events.
According to a news release, the trial focuses on harm reduction by using Aquablation as a first-line treatment compared to radical prostatectomy. Dr. Inderbir Gill, founding executive director of USC Urology, says it “could potentially change the way urologists treat localized prostate cancer for millions of men.”