WATER IV Prostate Cancer

Last updated: April 1, 2025
Sponsor: PROCEPT BioRobotics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Prostate Cancer, Early, Recurrent

Prostate 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 orunwilling or unable to follow study instructions including randomization andcomplete all required study visits through 10 years. This includes individuals withsevere cognitive disabilities, those under legal guardianship, or those currentlyincarcerated.

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

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

  • Centre Hospitalier de l'Université de Montréal

    Montréal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Clinique Pasteur

    Toulouse,
    France

    Site Not Available

  • Universitätsklinikum OWL der Universität Bielefeld

    Bielefeld,
    Germany

    Site Not Available

  • Chinese University of Hong Kong

    Shatin,
    Hong Kong

    Site Not Available

  • Hospital Cruz Vermelha

    Lisbon, 1549-008
    Portugal

    Site Not Available

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke, Hamsphire RG24 7A
    United Kingdom

    Site Not Available

  • University of Hertfordshire

    Hatfield, Hertfordshire AL10 9AB
    United Kingdom

    Site Not Available

  • Norfolk & Norwich University Hospital

    Colney, Norwich NR4 7UY
    United Kingdom

    Site Not Available

  • Guy's Hospital

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • 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

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90089
    United States

    Site Not Available

  • Boulder Medical Center

    Boulder, Colorado 80304
    United States

    Site Not Available

  • 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

  • Georgia Urology

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Endeavor Health

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66103
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Kansas City Urology Care

    North Kansas City, Missouri 64116
    United States

    Site Not Available

  • Kearney Urology Center

    Kearney, Nebraska 68847
    United States

    Active - Recruiting

  • Adult & Pediatric Urology

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Adult Pediatric Urology & Urogynecology

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • 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

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • MUSC

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Urology Associates PC

    Nashville, Tennessee 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

  • Potomac Urology

    Alexandria, Virginia 22311
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • Advocate Aurora Research Institute

    Sheboygan, Wisconsin 53081
    United States

    Site Not Available

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