🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06651632
Active, not recruiting Not applicable

WATER IV Prostate Cancer

NCT06651632 · tracked via the Priya Life Science UK tracker
Sponsor
PROCEPT BioRobotics
Phase
Not applicable
Started
2025-02-03
Last updated
2026-05-04

Condition(s) studied

Localized Prostate Cancer

Investigational drug(s) / intervention(s)

Aquablation TherapyRadical Prostatectomy

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.

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.

Study summary

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

Sex
MALE
Min age
45 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
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
Advocate Aurora Research Institute Sheboygan Wisconsin
University of Toronto Toronto Ontario
Centre Hospitalier de l'Université de Montréal Montreal Quebec
Universitätsklinikum OWL der Universität Bielefeld Bielefeld Germany
Chinese University of Hong Kong Shatin Hong Kong
Hospital da Cruz Vermelha Lisbon Portugal
National Taiwan University Hospital Taipei Taiwan
Hampshire Hospitals NHS Foundation Trust Basingstoke Hamsphire
Norfolk & Norwich University Hospital Colney Norwich
Guy's Hospital London United Kingdom
The Royal Marsden Hospital London United Kingdom
Royal Free Hospital London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06651632 on ClinicalTrials.gov ↗ ← All trials in the UK