WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer
Status: Recruiting
Location: See all (39) 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
NOT_YET_RECRUITING
Chandler
East Valley Urology Center
RECRUITING
Mesa
California
University of Southern California
RECRUITING
Los Angeles
Colorado
Boulder Medical Center
RECRUITING
Boulder
Florida
Advanced Research
RECRUITING
Delray Beach
University of Miami
NOT_YET_RECRUITING
Miami
Florida Urology Partners
RECRUITING
Tampa
Georgia
Georgia Urology
NOT_YET_RECRUITING
Atlanta
Illinois
University of Chicago
NOT_YET_RECRUITING
Chicago
Endeavor Health
RECRUITING
Glenview
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Louisiana
Ochsner Clinic Foundation
NOT_YET_RECRUITING
New Orleans
Missouri
Kansas City Urology Care
RECRUITING
North Kansas City
Nebraska
Kearney Urology Center
RECRUITING
Kearney
Adult & Pediatric Urology
RECRUITING
Omaha
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Icahn School of Medicine at Mount Sinai
NOT_YET_RECRUITING
New York
Integrated Medical Professionals, PLLC
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
NOT_YET_RECRUITING
Cleveland
Pennsylvania
Fox Chase Cancer Center
WITHDRAWN
Philadelphia
South Carolina
MUSC
NOT_YET_RECRUITING
Charleston
Tennessee
Urology Associates PC
NOT_YET_RECRUITING
Nashville
Texas
Urology Austin
RECRUITING
Austin
Urology Clinics of North Texas
NOT_YET_RECRUITING
Dallas
Virginia
Potomac Urology
RECRUITING
Alexandria
Washington
Swedish Medical Center
WITHDRAWN
Seattle
Wisconsin
Advocate Aurora Research Institute
RECRUITING
Sheboygan
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
University of Toronto
RECRUITING
Toronto
France
Clinique Pasteur
WITHDRAWN
Toulouse
Germany
Universitätsklinikum OWL der Universität Bielefeld
NOT_YET_RECRUITING
Bielefeld
Hong Kong Special Administrative Region
Chinese University of Hong Kong
RECRUITING
Shatin
Portugal
Hospital Cruz Vermelha
NOT_YET_RECRUITING
Lisbon
Taiwan
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
United Kingdom
Hampshire Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Basingstoke
Norfolk & Norwich University Hospital
RECRUITING
Colney
University of Hertfordshire
NOT_YET_RECRUITING
Hatfield
Guy's Hospital
RECRUITING
London
The Royal Marsden Hospital
RECRUITING
London
Contact Information
Primary
Angela Lee
a.lee@procept-biorobotics.com
650-232-7215
Time Frame
Start Date: 2025-02-03
Estimated 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