In plain English
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Official title
WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer
About this study
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.
Eligibility criteria
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 design
Enrollment target: 280 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-03
Estimated completion: 2037-01
Last updated: 2026-03-31
Interventions
Device: Aquablation TherapyProcedure: Radical Prostatectomy
Primary outcomes
- • Rate of pad use for urinary incontinence (6 Months)
- • Rate of erectile dysfunction (6 Months)
Sponsor
PROCEPT BioRobotics · industry
Contacts & investigators
ContactAngela Lee · contact · a.lee@procept-biorobotics.com · 650-232-7215
All locations (37)
Arizona State Urological InstituteRecruiting
Chandler, Arizona, United States
East Valley Urology CenterRecruiting
Mesa, Arizona, United States
University of Southern CaliforniaRecruiting
Los Angeles, California, United States
Boulder Medical CenterRecruiting
Boulder, Colorado, United States
Advanced ResearchRecruiting
Delray Beach, Florida, United States
University of MiamiRecruiting
Miami, Florida, United States
Florida Urology PartnersRecruiting
Tampa, Florida, United States
Trophy Point UrologyRecruiting
Tampa, Florida, United States
Georgia UrologyRecruiting
Atlanta, Georgia, United States
Mountain View HospitalRecruiting
Idaho Falls, Idaho, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Endeavor HealthRecruiting
Glenview, Illinois, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Kansas City Urology CareRecruiting
North Kansas City, Missouri, United States
Kearney Urology CenterRecruiting
Kearney, Nebraska, United States
Adult & Pediatric UrologyRecruiting
Omaha, Nebraska, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Integrated Medical Professionals, PLLCRecruiting
New York, New York, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
MUSC Hollings Cancer CenterRecruiting
Charleston, South Carolina, United States
Tidelands Health UrologyNot Yet Recruiting
Murrells Inlet, South Carolina, United States
Urology AustinRecruiting
Austin, Texas, United States
Urology Clinics of North TexasRecruiting
Dallas, Texas, United States
Potomac UrologyRecruiting
Alexandria, Virginia, United States
Advocate Aurora Research InstituteRecruiting
Sheboygan, Wisconsin, United States
University of TorontoRecruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de MontréalRecruiting
Montreal, Quebec, Canada
Universitätsklinikum OWL der Universität BielefeldRecruiting
Bielefeld, Germany
Chinese University of Hong KongRecruiting
Shatin, Hong Kong
Hospital da Cruz VermelhaRecruiting
Lisbon, Portugal
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Hampshire Hospitals NHS Foundation TrustRecruiting
Basingstoke, Hamsphire, United Kingdom
Norfolk & Norwich University HospitalRecruiting
Colney, Norwich, United Kingdom
Guy's HospitalRecruiting
London, United Kingdom
The Royal Marsden HospitalRecruiting
London, United Kingdom
Royal Free HospitalRecruiting
London, United Kingdom