WATER IV Prostate Cancer

Last updated: January 21, 2026
Sponsor: PROCEPT BioRobotics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Prostate Cancer

Urologic Cancer

Treatment

Radical Prostatectomy

Aquablation Therapy

Clinical Study ID

NCT06651632
CSP0005
  • Ages > 45
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Biological male with age ≥ 45 years at the time of consent

  2. Biopsy positive Grade Group 1-3 prostate cancer

  3. Are candidates for prostatectomy or, in the case of GG1 disease, have alreadyselected a radical therapy as their treatment.

  4. Clinical Stage ≤ T2c

  5. PSA ≤ 20 ng/ml

  6. Prostate volume ≥25 ml

Exclusion

Exclusion Criteria:

  1. Any prior or current local or systemic treatment for prostate cancer, including butnot limited to surgery, radiation therapy (external or brachytherapy), tissueablation, hormone therapy or chemotherapy.

  2. Patients with previous surgical or minimally invasive treatment of benign prostatichyperplasia within the prior 3 months of study treatment.

  3. Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicleinvasion.

  4. Patient is unwilling to accept a blood transfusion if required.

  5. Any condition or history of illness or surgery that may pose an additional risk topatients undergoing the Aquablation or radical prostatectomy procedure such as:

5a. Medical conditions that preclude the use of anesthesia; 5b. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of rectal injury (i.e. fistula formation); 5c. Patient is unable to stop anticoagulants or antiplatelet agents prior to study treatment per standard of care; 5d. Any other condition or history of infection, illness or surgery that in the opinion of the investigator might affect the outcome of the study procedure, study conduct, and study results; or pose additional risks to the patient (e.g., other cancer, active urethral stricture disease).

  1. Patients who are unable to provide informed consent due to cognitive impairment, legal status (such as incarceration), or other factors limiting autonomy or unwilling or unable to follow study instructions including randomization and complete all required study visits through 10 years. This includes individuals with severe cognitive disabilities, those under legal guardianship, or those currently incarcerated.

  2. Patient currently participating in other studies unless approved by Sponsor in writing.

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: Radical Prostatectomy
Phase:
Study Start date:
February 03, 2025
Estimated Completion Date:
January 31, 2037

Connect with a study center

  • University of Toronto

    Toronto, Ontario M5S3H2
    Canada

    Site Not Available

  • University of Toronto

    Toronto 6167865, Ontario 6093943 M5S3H2
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montréal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal

    Montreal 6077243, Quebec 6115047 H2X 0A9
    Canada

    Active - Recruiting

  • Clinique Pasteur

    Toulouse,
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse 2972315,
    France

    Site Not Available

  • Universitätsklinikum OWL der Universität Bielefeld

    Bielefeld,
    Germany

    Site Not Available

  • Universitätsklinikum OWL der Universität Bielefeld

    Bielefeld 2949186,
    Germany

    Active - Recruiting

  • Chinese University of Hong Kong

    Shatin,
    Hong Kong

    Site Not Available

  • Chinese University of Hong Kong

    Shatin 1818920,
    Hong Kong

    Active - Recruiting

  • Hospital Cruz Vermelha

    Lisbon, 1549-008
    Portugal

    Site Not Available

  • Hospital Cruz Vermelha

    Lisbon 2267057, 1549-008
    Portugal

    Site Not Available

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341,
    Taiwan

    Site Not Available

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke, Hamsphire RG24 7A
    United Kingdom

    Site Not Available

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke 2656192, Hamsphire RG24 7A
    United Kingdom

    Active - Recruiting

  • University of Hertfordshire

    Hatfield, Hertfordshire AL10 9AB
    United Kingdom

    Site Not Available

  • University of Hertfordshire

    Hatfield 2647349, Hertfordshire AL10 9AB
    United Kingdom

    Site Not Available

  • Norfolk & Norwich University Hospital

    Colney, Norwich NR4 7UY
    United Kingdom

    Site Not Available

  • Norfolk & Norwich University Hospital

    Colney 2652540, Norwich NR4 7UY
    United Kingdom

    Active - Recruiting

  • Guy's Hospital

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • Guy's Hospital

    London 2643743, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital

    London 2643743,
    United Kingdom

    Active - Recruiting

  • The Royal Marsden Hospital

    London 2643743, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • Arizona State Urological Institute

    Chandler, Arizona 85224
    United States

    Site Not Available

  • East Valley Urological Center

    Mesa, Arizona 85206
    United States

    Site Not Available

  • East Valley Urology Center

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Arizona State Urological Institute

    Chandler 5289282, Arizona 5551752 85224
    United States

    Active - Recruiting

  • East Valley Urology Center

    Mesa 5304391, Arizona 5551752 85206
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90089
    United States

    Site Not Available

  • University of Southern California

    Los Angeles 5368361, California 5332921 90089
    United States

    Active - Recruiting

  • Boulder Medical Center

    Boulder, Colorado 80304
    United States

    Site Not Available

  • Boulder Medical Center

    Boulder 5574991, Colorado 5417618 80304
    United States

    Active - Recruiting

  • Advanced Research

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33146
    United States

    Site Not Available

  • Florida Urology Partners

    Tampa, Florida 33606
    United States

    Site Not Available

  • Advanced Research

    Delray Beach 4153132, Florida 4155751 33484
    United States

    Active - Recruiting

  • University of Miami

    Miami 4164138, Florida 4155751 33146
    United States

    Active - Recruiting

  • Florida Urology Partners

    Tampa 4174757, Florida 4155751 33606
    United States

    Active - Recruiting

  • Trophy Point Urology

    Tampa 4174757, Florida 4155751 33607
    United States

    Active - Recruiting

  • Georgia Urology

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Georgia Urology

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Active - Recruiting

  • Mountain View Hospital

    Idaho Falls 5596475, Idaho 5596512 83401
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Endeavor Health

    Glenview, Illinois 60026
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Endeavor Health

    Glenview 4893886, Illinois 4896861 60026
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66103
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66103
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Kansas City Urology Care

    North Kansas City, Missouri 64116
    United States

    Site Not Available

  • Kansas City Urology Care

    North Kansas City 4400860, Missouri 4398678 64116
    United States

    Active - Recruiting

  • Kearney Urology Center

    Kearney, Nebraska 68847
    United States

    Site Not Available

  • Adult & Pediatric Urology

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Adult Pediatric Urology & Urogynecology

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Kearney Urology Center

    Kearney 5071348, Nebraska 5073708 68847
    United States

    Active - Recruiting

  • Adult & Pediatric Urology

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Northwell Health

    New York, New York 10075
    United States

    Site Not Available

  • Solaris Health

    New York, New York 10016
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York City, New York 10029
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Integrated Medical Professionals, PLLC

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Solaris Health

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14642
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19111
    United States

    Site Not Available

  • MUSC

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • MUSC

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Urology Associates PC

    Nashville, Tennessee 37209
    United States

    Site Not Available

  • Urology Associates PC

    Nashville 4644585, Tennessee 4662168 37209
    United States

    Site Not Available

  • Urology Austin

    Austin, Texas 78745
    United States

    Site Not Available

  • Objective Health

    Dallas, Texas 76017
    United States

    Site Not Available

  • Urology Clinics of North Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Urology Austin

    Austin 4671654, Texas 4736286 78745
    United States

    Active - Recruiting

  • Urology Clinics of North Texas

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Potomac Urology

    Alexandria, Virginia 22311
    United States

    Site Not Available

  • Potomac Urology

    Alexandria 4744091, Virginia 6254928 22311
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

  • Advocate Aurora Research Institute

    Sheboygan, Wisconsin 53081
    United States

    Site Not Available

  • Advocate Aurora Research Institute

    Sheboygan 5272893, Wisconsin 5279468 53081
    United States

    Active - Recruiting

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