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WATER IV Prostate Cancer
Sponsor: PROCEPT BioRobotics
Summary
This is a multicenter, prospective, randomized clinical trial that aims to assess the safety and efficacy of Aquablation Therapy in men with low-risk to intermediate to high-risk localized prostate cancer who are candidates for, or have opted for, prostatectomy. Participants will be randomized to either Aquablation Therapy or radical prostatectomy and followed up to 10 years.
Official title: WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer
Key Details
Gender
MALE
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2025-02-03
Completion Date
2037-01
Last Updated
2026-03-31
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.
Radical Prostatectomy
Radical prostatectomy is a surgery that is performed through an incision in the lower abdomen or perineum, or with a laparoscope or robotic system to remove the entire prostate gland.
Locations (37)
Arizona State Urological Institute
Chandler, Arizona, United States
East Valley Urology Center
Mesa, Arizona, United States
University of Southern California
Los Angeles, California, United States
Boulder Medical Center
Boulder, Colorado, United States
Advanced Research
Delray Beach, Florida, United States
University of Miami
Miami, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Trophy Point Urology
Tampa, Florida, United States
Georgia Urology
Atlanta, Georgia, United States
Mountain View Hospital
Idaho Falls, Idaho, United States
University of Chicago
Chicago, Illinois, 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
Integrated Medical Professionals, PLLC
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, 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 Austin
Austin, Texas, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Potomac Urology
Alexandria, Virginia, United States
Advocate Aurora Research Institute
Sheboygan, Wisconsin, United States
University of Toronto
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Universitätsklinikum OWL der Universität Bielefeld
Bielefeld, Germany
Chinese University of Hong Kong
Shatin, Hong Kong
Hospital da Cruz Vermelha
Lisbon, Portugal
National Taiwan University Hospital
Taipei, Taiwan
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hamsphire, United Kingdom
Norfolk & Norwich University Hospital
Colney, Norwich, United Kingdom
Guy's Hospital
London, United Kingdom
The Royal Marsden Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom