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RECRUITING
NCT06651632
NA

WATER IV Prostate Cancer

Sponsor: PROCEPT BioRobotics

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

PROCEDURE

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