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Water jet surgery could offer new option for prostate cancer patients

NCT ID NCT07650448

Disease control Sponsor: PROCEPT BioRobotics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study compares a robotic water-jet procedure called Aquablation to active surveillance (close monitoring) in 333 men with low- or intermediate-risk localized prostate cancer. The goal is to see if Aquablation can better prevent cancer from progressing to a more serious grade. Participants will be followed for several years to track cancer outcomes and the need for additional treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aquablation therapy (water-jet tissue removal using the AquaBeam or HYDROS Robotic System)
What this could lead to
If successful, this could offer men with localized prostate cancer a minimally invasive option that lowers the chance of cancer worsening compared to just watching and waiting.
What could go wrong
This is an early-stage trial with no results yet, and the procedure carries surgical risks like bleeding, infection, or urinary problems. It may not prove better than active surveillance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 333 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2038

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Biological male with age ≥ 45 years at the time of consent 2. Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3) 3. First prostate cancer diagnoses within 18 months (545 days) of consent 4. Are candidates for active surveillance 5. Clinical Stage ≤ T2c 6. PSA \< 15 ng/ml 7. 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. 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).

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Localized prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adult & Pediatric Urology

    Omaha, Nebraska, 68114, United States

  • Advanced Research

    Delray Beach, Florida, 33484, United States

  • Advocate Aurora Research Institute

    Sheboygan, Wisconsin, 53081, United States

  • Albany Medical College

    Albany, New York, 12208, United States

  • Arizona Clinical Trials

    Chandler, Arizona, 85224, United States

  • Boulder Medical Center

    Boulder, Colorado, 80304, United States

  • Chinese University of Hong Kong

    Shatin, Hong Kong

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Endeavor Health

    Glenview, Illinois, 60026, United States

  • Georgia Urology

    Atlanta, Georgia, 30328, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Integrated Medical Professionals, PLLC

    New York, New York, 10016, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Kansas City Urology Care

    North Kansas City, Missouri, 64116, United States

  • Kearney Urology Center

    Kearney, Nebraska, 68847, United States

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • Mountain View Hospital

    Idaho Falls, Idaho, 83401, United States

  • Tidelands Health Urology

    Murrells Inlet, South Carolina, 29576, United States

  • Tri Valley Urology

    Murrieta, California, 92562, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33146, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Southern California

    Los Angeles, California, 90089, United States

  • Urology Austin

    Austin, Texas, 78745, United States

  • Urology Clinics of North Texas

    Dallas, Texas, 75231, United States

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