RecruitingNot ApplicableNCT06651632

WATER IV Prostate Cancer

WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer

Sponsor

PROCEPT BioRobotics

Enrollment

280 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

Localized Prostate Cancer

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

Sex: MALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a water-based therapy technique called WATER (Water Ablation Therapy for Early-stage prostate cancer with Robotic assistance) — a minimally invasive treatment that destroys prostate tissue using targeted high-pressure water vapor — as an alternative to surgery for early-stage prostate cancer. **You may be eligible if...** - You are a biological male aged 45 or older - You have been diagnosed with low to intermediate risk prostate cancer (Grade Group 1–3) - Your prostate cancer has not spread beyond the prostate (stage T2c or lower) - Your PSA level is 20 ng/mL or below - Your prostate is at least 25 mL in volume - You are a candidate for surgical removal of the prostate, or you have chosen active treatment for low-grade disease **You may NOT be eligible if...** - You have had previous prostate surgery, radiation, hormone therapy, or any treatment for prostate cancer - You recently had surgery for benign prostate enlargement (within the past 3 months) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAquablation 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.

PROCEDURERadical 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06651632

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