WATER IV Prostate Cancer (WATER IV PCa)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Localized Prostate Cancer
• Intervention / Treatment: Device: Aquablation Therapy; Procedure: Radical Prostatectomy

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S3H2
      • University of Toronto
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Université de Montréal
• Germany
  • Bielefeld, Germany
    • Universitätsklinikum OWL der Universität Bielefeld
• Hong Kong
  • Shatin, Hong Kong
    • Chinese University of Hong Kong
• Portugal
  • Lisbon, Portugal, 1549-008
    • Hospital da Cruz Vermelha
• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom
    • Royal Free Hospital
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden Hospital
  • Hamsphire
    • Basingstoke, Hamsphire, United Kingdom, RG24 7A
      • Hampshire Hospitals NHS Foundation Trust
  • Norwich
    • Colney, Norwich, United Kingdom, NR4 7UY
      • Norfolk & Norwich University Hospital
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona State Urological Institute
    • Mesa, Arizona, United States, 85206
      • East Valley Urology Center
  • California
    • Los Angeles, California, United States, 90089
      • University of Southern California
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Boulder Medical Center
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Advanced Research
    • Miami, Florida, United States, 33146
      • University of Miami
    • Tampa, Florida, United States, 33606
      • Florida Urology Partners
    • Tampa, Florida, United States, 33607
      • Trophy Point Urology
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Georgia Urology
  • Idaho
    • Idaho Falls, Idaho, United States, 83401
      • Mountain View Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Glenview, Illinois, United States, 60026
      • Endeavor Health
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Missouri
    • North Kansas City, Missouri, United States, 64116
      • Kansas City Urology Care
  • Nebraska
    • Kearney, Nebraska, United States, 68847
      • Kearney Urology Center
    • Omaha, Nebraska, United States, 68114
      • Adult & Pediatric Urology
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10016
      • Integrated Medical Professionals, PLLC
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Hollings Cancer Center
    • Murrells Inlet, South Carolina, United States, 29576
      • Tidelands Health Urology
  • Texas
    • Austin, Texas, United States, 78745
      • Urology Austin
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
  • Virginia
    • Alexandria, Virginia, United States, 22311
      • Potomac Urology
  • Wisconsin
    • Sheboygan, Wisconsin, United States, 53081
      • Advocate Aurora Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 already selected a radical therapy as their treatment.
4. Clinical Stage ≤ T2c
5. PSA ≤ 20 ng/ml
6. Prostate volume ≥25 ml

Exclusion Criteria:

1. 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.
2. Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.
3. Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.
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 to patients 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).

6. 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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aquablation Therapy; The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System	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.
Active Comparator: Radical Prostatectomy; The radical prostatectomy arm will receive the standard of care radical prostatectomy procedure.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of pad use for urinary incontinence	6 Months
Rate of erectile dysfunction	6 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: PROCEPT BioRobotics

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2037

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Prostate cancer; radical prostatectomy; Aquablation; AQUABEAM; Aquablation therapy; HYDROS
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CSP0005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No