WATER IV Prostate Cancer

NCT06651632 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CSP0005
• Study Type: interventional
• Target: 280
• Locations: 7 countries
• Sites: 37

Brief 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.

Conditions

Localized Prostate Cancer

Keywords

Aquablation therapy; Aquablation; Prostate cancer; AQUABEAM; radical prostatectomy; HYDROS

Outcome Measures

Primary Outcomes (2)

• Rate of pad use for urinary incontinence

  6 Months

• Rate of erectile dysfunction

  6 Months

Secondary Outcomes (3)

• Rate of pad use for urinary incontinence

  3 Months

• Rate of erectile dysfunction

  3 Months

• Stable or improved Grade Group at 1 year compared to baseline (Aquablation arm only)

  1 Year

Study Arms (2)

Aquablation Therapy

EXPERIMENTAL

The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System

Device: Aquablation Therapy

Radical Prostatectomy

ACTIVE COMPARATOR

The radical prostatectomy arm will receive the standard of care radical prostatectomy procedure.

Procedure: Radical Prostatectomy

Interventions

Aquablation Therapy DEVICE

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.

Aquablation Therapy

Radical Prostatectomy PROCEDURE

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.

Radical Prostatectomy

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any prior or current local or systemic treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation, hormone therapy or chemotherapy.
• Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.
• Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.
• Patient is unwilling to accept a blood transfusion if required.
• Any condition or history of illness or surgery that may pose an additional risk to patients undergoing the Aquablation or radical prostatectomy procedure such as:
• a. 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).
• \. 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.
• \. Patient currently participating in other studies unless approved by Sponsor in writing.

Sponsors & Collaborators

• PROCEPT BioRobotics: lead

Study Sites (37)

Arizona State Urological Institute

Chandler, Arizona, 85224, United States

Location

East Valley Urology Center

Mesa, Arizona, 85206, United States

Location

University of Southern California

Los Angeles, California, 90089, United States

Location

Boulder Medical Center

Boulder, Colorado, 80304, United States

Location

Advanced Research

Delray Beach, Florida, 33484, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

Florida Urology Partners

Tampa, Florida, 33606, United States

Location

Trophy Point Urology

Tampa, Florida, 33607, United States

Location

Georgia Urology

Atlanta, Georgia, 30328, United States

Location

Mountain View Hospital

Idaho Falls, Idaho, 83401, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Endeavor Health

Glenview, Illinois, 60026, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Kansas City Urology Care

North Kansas City, Missouri, 64116, United States

Location

Kearney Urology Center

Kearney, Nebraska, 68847, United States

Location

Adult & Pediatric Urology

Omaha, Nebraska, 68114, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Integrated Medical Professionals, PLLC

New York, New York, 10016, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Tidelands Health Urology

Murrells Inlet, South Carolina, 29576, United States

Location

Urology Austin

Austin, Texas, 78745, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Potomac Urology

Alexandria, Virginia, 22311, United States

Location

Advocate Aurora Research Institute

Sheboygan, Wisconsin, 53081, United States

Location

University of Toronto

Toronto, Ontario, M5S3H2, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Universitätsklinikum OWL der Universität Bielefeld

Bielefeld, Germany

Location

Chinese University of Hong Kong

Shatin, Hong Kong

Location

Hospital da Cruz Vermelha

Lisbon, 1549-008, Portugal

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hamsphire, RG24 7A, United Kingdom

Location

Norfolk & Norwich University Hospital

Colney, Norwich, NR4 7UY, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2037
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

GB (5); US (26); CA (2); DE (1); HK (1); PT (1); TW (1)