🏛️ Verified NIH Record • Updated 2026-07-31

WATER IV PCa (AS Sub-study) (NCT07650448)

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

🟡 Not Yet Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: PROCEPT BioRobotics

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (6 items).

Location: Arizona Clinical Trials — Chandler, Arizona

Age range: 45 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check 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. 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).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (25 Sites)

  • Arizona Clinical Trials — Chandler, Arizona
  • University of Southern California — Los Angeles, California
  • Tri Valley Urology — Murrieta, California
  • Boulder Medical Center — Boulder, Colorado
  • Advanced Research — Delray Beach, Florida
  • University of Miami — Miami, 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
  • Albany Medical College — Albany, New York
  • 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
  • Advocate Aurora Research Institute — Sheboygan, Wisconsin
  • Chinese University of Hong Kong — Shatin,

📞 Contact the Study Coordinator

Phone: (650) 232-7215

Email: a.lee@procept-biorobotics.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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.

More studies in Localized Prostate Cancer

Explore by condition: All Localized Prostate Cancer clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗