WATER IV PCa (AS Sub-study)

July 31, 2026 updated by: PROCEPT BioRobotics

WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer

The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The WATER IV AS sub-study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with low to intermediate risk localized prostate cancer who are candidates for active surveillance. Participants will be randomized to either Aquablation Therapy or active surveillance and followed up to 10 years.

Study Type

Interventional

Enrollment (Estimated)

333

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Chinese University of Hong Kong
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Clinical Trials
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California
      • Murrieta, California, United States, 92562
        • Tri Valley Urology
    • 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
    • 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
      • Albany, New York, United States, 12208
        • Albany Medical College
      • 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
    • Wisconsin
      • Sheboygan, Wisconsin, United States, 53081
        • Advocate Aurora Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3)
  3. First prostate cancer diagnoses within 18 months (545 days) of consent
  4. Are candidates for active surveillance
  5. Clinical Stage ≤ T2c
  6. PSA < 15 ng/ml
  7. 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.

8. More than one complete biopsy beyond the diagnostic biopsy comprising both a systematic biopsy and biopsy of any MRI visible lesion (PI-RADS/Likert ≥ 3).

9. GG2 disease with PSA ≥ 10 OR stage ≥ T2b OR ≥ 50% of biopsy cores positive (multiple cores taken from any MRI visible lesion are counted as one continuous core).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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: Active Surveillance
The active surveillance arm will receive standard-of-care for prostate cancer management.
Other: Active Surveillance
Active surveillance is a management strategy for men with low- and favorable intermediate-risk localized prostate cancer that involves close monitoring with curative intent, reserving treatment for evidence of disease progression. Monitoring typically includes serial PSA testing, periodic prostate MRI, and repeat biopsies at scheduled intervals, with intervention triggered by evidence of disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from GG ≥ 2
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from persistent or increased MRI suspicion AND additional prostate cancer treatment
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PROCEPT BioRobotics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2038

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP0005 - AS Sub-study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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