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WATER IV PCa (AS Sub-study)
Sponsor: PROCEPT BioRobotics
Summary
The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.
Official title: WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer
Key Details
Gender
MALE
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
333
Start Date
2026-09
Completion Date
2038-12
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
Aquablation Therapy
The AquaBeam Robotic System and the HYDROS Robotic System utilize high-velocity sterile saline waterjet to resect prostate tissue, guided by real-time visualization through cystoscopy and transrectal ultrasound imaging. This minimally invasive surgical procedure is called the Aquablation therapy.
Active Surveillance
Active surveillance is a management strategy for men with low- and favorable intermediate-risk localized prostate cancer that involves close monitoring with curative intent, reserving treatment for evidence of disease progression. Monitoring typically includes serial PSA testing, periodic prostate MRI, and repeat biopsies at scheduled intervals, with intervention triggered by evidence of disease progression.
Locations (17)
Arizona State Urological Institute
Chandler, Arizona, United States
University of Southern California
Los Angeles, California, United States
Boulder Medical Center
Boulder, Colorado, United States
University of Miami
Miami, Florida, United States
Georgia Urology
Atlanta, Georgia, United States
Mountain View Hospital
Idaho Falls, Idaho, United States
Endeavor Health
Glenview, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Kansas City Urology Care
North Kansas City, Missouri, United States
Kearney Urology Center
Kearney, Nebraska, United States
Adult & Pediatric Urology
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
Tidelands Health Urology
Murrells Inlet, South Carolina, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Advocate Aurora Research Institute
Sheboygan, Wisconsin, United States