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Clinical Trials
NCT06651632

WATER IV Prostate Cancer

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2037-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Localized Prostate Cancer

Keywords

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Aquablation therapy Aquablation Prostate cancer AQUABEAM radical prostatectomy HYDROS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aquablation Therapy

The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System

Group Type EXPERIMENTAL

Aquablation Therapy

Intervention Type DEVICE

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

The radical prostatectomy arm will receive the standard of care radical prostatectomy procedure.

Group Type ACTIVE_COMPARATOR

Radical Prostatectomy

Intervention Type PROCEDURE

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.

Interventions

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Aquablation Therapy

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

London, , United Kingdom

Site Status RECRUITING

Countries

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WATER IV Prostate Cancer

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Aquablation Therapy

Aquablation Therapy

Radical Prostatectomy

Radical Prostatectomy

Interventions

Aquablation Therapy

Radical Prostatectomy

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

PROCEPT BioRobotics

Responsible Party

Locations

Arizona State Urological Institute

East Valley Urology Center

University of Southern California

Boulder Medical Center

Advanced Research

University of Miami

Florida Urology Partners

Georgia Urology

University of Chicago

Endeavor Health

University of Kansas Medical Center

Ochsner Clinic Foundation

Kansas City Urology Care

Kearney Urology Center

Adult & Pediatric Urology

Hackensack University Medical Center

Integrated Medical Professionals, PLLC

Icahn School of Medicine at Mount Sinai

University of Rochester Medical Center

Cleveland Clinic Foundation

Fox Chase Cancer Center

MUSC

Urology Associates PC

Urology Austin

Urology Clinics of North Texas

Potomac Urology

Swedish Medical Center

Advocate Aurora Research Institute

University of Toronto

Centre Hospitalier de l'Université de Montréal

Clinique Pasteur

Universitätsklinikum OWL der Universität Bielefeld

Chinese University of Hong Kong

Hospital Cruz Vermelha

National Taiwan University Hospital

Hampshire Hospitals NHS Foundation Trust

University of Hertfordshire

Norfolk & Norwich University Hospital

Guy's Hospital

The Royal Marsden Hospital

Countries

Central Contacts

Angela Lee

Facility Contacts

Dianna Baldanado

Marchelle Mehan

Ileana Aldana

Stephanie Leonard

Julia Conceição

Laura Ochoa

Haydy Rojas

Lydia Jordan

Briana Harrison

Rincy Regi

Rose Sachedina

Rachel Graham

Judy Searcy