🏛️ Verified NIH Record • Updated 2026-05-01
WATER IV Prostate Cancer (NCT06651632)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: PROCEPT BioRobotics
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (6 items).
Location: Arizona State Urological Institute — Chandler, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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: 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (37 Sites)
- Arizona State Urological Institute — Chandler, Arizona
- East Valley Urology Center — Mesa, Arizona
- University of Southern California — Los Angeles, California
- Boulder Medical Center — Boulder, Colorado
- Advanced Research — Delray Beach, Florida
- University of Miami — Miami, Florida
- Florida Urology Partners — Tampa, Florida
- Trophy Point Urology — Tampa, Florida
- Georgia Urology — Atlanta, Georgia
- Mountain View Hospital — Idaho Falls, Idaho
- University of Chicago — Chicago, Illinois
- Endeavor Health — Glenview, Illinois
- Johns Hopkins University — Baltimore, Maryland
- Kansas City Urology Care — North Kansas City, Missouri
- Kearney Urology Center — Kearney, Nebraska
- Adult & Pediatric Urology — Omaha, Nebraska
- Hackensack University Medical Center — Hackensack, New Jersey
- Integrated Medical Professionals, PLLC — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Cleveland Clinic Foundation — Cleveland, Ohio
- MUSC Hollings Cancer Center — Charleston, South Carolina
- Tidelands Health Urology — Murrells Inlet, South Carolina
- Urology Austin — Austin, Texas
- Urology Clinics of North Texas — Dallas, Texas
- Potomac Urology — Alexandria, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.