WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer
Status: Active_not_recruiting
Location: See all (37) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 45
Healthy Volunteers: f
View:
• Biological male with age ≥ 45 years at the time of consent
• Biopsy positive Grade Group 1-3 prostate cancer
• Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment.
• Clinical Stage ≤ T2c
• PSA ≤ 20 ng/ml
• Prostate volume ≥25 ml
Locations
United States
Arizona
Arizona State Urological Institute
Chandler
East Valley Urology Center
Mesa
California
University of Southern California
Los Angeles
Colorado
Boulder Medical Center
Boulder
Florida
Advanced Research
Delray Beach
University of Miami
Miami
Florida Urology Partners
Tampa
Trophy Point Urology
Tampa
Georgia
Georgia Urology
Atlanta
Idaho
Mountain View Hospital
Idaho Falls
Illinois
University of Chicago
Chicago
Endeavor Health
Glenview
Maryland
Johns Hopkins University
Baltimore
Missouri
Kansas City Urology Care
North Kansas City
Nebraska
Kearney Urology Center
Kearney
Adult & Pediatric Urology
Omaha
New Jersey
Hackensack University Medical Center
Hackensack
New York
Integrated Medical Professionals, PLLC
New York
University of Rochester Medical Center
Rochester
Ohio
Cleveland Clinic Foundation
Cleveland
South Carolina
MUSC Hollings Cancer Center
Charleston
Tidelands Health Urology
Murrells Inlet
Texas
Urology Austin
Austin
Urology Clinics of North Texas
Dallas
Virginia
Potomac Urology
Alexandria
Wisconsin
Advocate Aurora Research Institute
Sheboygan
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal
Montreal
University of Toronto
Toronto
Germany
Universitätsklinikum OWL der Universität Bielefeld
Bielefeld
Hong Kong Special Administrative Region
Chinese University of Hong Kong
Shatin
Portugal
Hospital da Cruz Vermelha
Lisbon
Taiwan
National Taiwan University Hospital
Taipei
United Kingdom
Hampshire Hospitals NHS Foundation Trust
Basingstoke
Norfolk & Norwich University Hospital
Colney
Guy's Hospital
London
Royal Free Hospital
London
The Royal Marsden Hospital
London
Time Frame
Start Date: 2025-02-03
Completion Date: 2037-01
Participants
Target number of participants: 280
Treatments
Experimental: Aquablation Therapy
The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System
Active_comparator: Radical Prostatectomy
The radical prostatectomy arm will receive the standard of care radical prostatectomy procedure.
Related Therapeutic Areas
Sponsors
Leads: PROCEPT BioRobotics