Localized Prostate CancerWATER IV PCaNCT06651632
WATER IV Prostate Cancer
A study testing Aquablation Therapy and Radical Prostatectomy in people with Localized Prostate Cancer, run by PROCEPT BioRobotics at 37 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Localized Prostate Cancer
- What is being tested?
- Aquablation Therapy and Radical Prostatectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 3 Feb 2025to Jan 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biological male with age ≥ 45 years at the time of consent
- Biopsy positive Grade Group 1-3 prostate cancer
- Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment.
- Clinical Stage ≤ T2c
- PSA ≤ 20 ng/ml
- Prostate volume ≥25 ml
Who cannot join
- 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.
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
United States26 sites
Potomac Urology
Alexandria, Virginia, 22311
Georgia Urology
Atlanta, Georgia, 30328
Urology Austin
Austin, Texas, 78745
Johns Hopkins University
Baltimore, Maryland, 21287
Boulder Medical Center
Boulder, Colorado, 80304
Arizona State Urological Institute
Chandler, Arizona, 85224
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Urology Clinics of North Texas
Dallas, Texas, 75231
Advanced Research
Delray Beach, Florida, 33484
Endeavor Health
Glenview, Illinois, 60026
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Mountain View Hospital
Idaho Falls, Idaho, 83401
Kearney Urology Center
Kearney, Nebraska, 68847
University of Southern California
Los Angeles, California, 90089
East Valley Urology Center
Mesa, Arizona, 85206
University of Miami
Miami, Florida, 33146
Tidelands Health Urology
Murrells Inlet, South Carolina, 29576
Integrated Medical Professionals, PLLC
New York, New York, 10016
Kansas City Urology Care
North Kansas City, Missouri, 64116
Adult & Pediatric Urology
Omaha, Nebraska, 68114
University of Rochester Medical Center
Rochester, New York, 14642
Advocate Aurora Research Institute
Sheboygan, Wisconsin, 53081
Florida Urology Partners
Tampa, Florida, 33606
Trophy Point Urology
Tampa, Florida, 33607
United Kingdom5 sites
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hamsphire, RG24 7A
Norfolk & Norwich University Hospital
Colney, Norwich, NR4 7UY
Guy's Hospital
London, SE1 9RT
The Royal Marsden Hospital
London, SW3 6JJ
Royal Free Hospital
London
Canada2 sites
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
University of Toronto
Toronto, Ontario, M5S3H2
About this study
Official title: WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer
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.
- Conditions
- Localized Prostate Cancer
- Being tested
- Aquablation Therapy, Radical Prostatectomy
- Keywords
- Aquablation therapy, Aquablation, Prostate cancer, AQUABEAM, radical prostatectomy, HYDROS
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquablation TherapyDevice
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 ProstatectomyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Aquablation Therapy | Experimental | The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System Receives: Device: Aquablation Therapy |
| Radical Prostatectomy | Active comparator | The radical prostatectomy arm will receive the standard of care radical prostatectomy procedure. Receives: Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pad use for urinary incontinence
Measured: 6 Months
Rate of erectile dysfunction
Measured: 6 Months
Secondary outcomes (3)
Rate of pad use for urinary incontinence
Measured: 3 Months
Rate of erectile dysfunction
Measured: 3 Months
Stable or improved Grade Group at 1 year compared to baseline (Aquablation arm only)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start3 Feb 2025
- Primary completionJul 2027 (estimated)
- Study completionJan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PROCEPT BioRobotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651632
- Sponsor's protocol ID
- CSP0005
- Acronym
- WATER IV PCa
- Status last verified
- May 2026
- First submitted
- 18 Oct 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT06651632
- Acronym / sponsor ID
- WATER IV PCa / CSP0005
- Conditions
- Localized Prostate Cancer
- Keywords
- Aquablation therapy, Aquablation, Prostate cancer, AQUABEAM, radical prostatectomy, HYDROS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- PROCEPT BioRoboticsIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2037 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquablation Therapy | Experimental | Device: Aquablation TherapyThe Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System |
| Radical Prostatectomy | Active comparator | Procedure: Radical ProstatectomyThe radical prostatectomy arm will receive the standard of care radical prostatectomy procedure. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biological male with age ≥ 45 years at the time of consent
- Biopsy positive Grade Group 1-3 prostate cancer
- Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment.
- Clinical Stage ≤ T2c
- PSA ≤ 20 ng/ml
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquablation TherapyThe 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. | Device | Aquablation Therapy |
| Radical ProstatectomyRadical 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. | Procedure or surgery | Radical Prostatectomy |
Primary outcome
Rate of pad use for urinary incontinence
Time frame: 6 Months
Rate of erectile dysfunction
Time frame: 6 Months
3 secondary outcomes
Rate of pad use for urinary incontinence
Time frame: 3 Months
Rate of erectile dysfunction
Time frame: 3 Months
Stable or improved Grade Group at 1 year compared to baseline (Aquablation arm only)
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquablation Therapy and Radical Prostatectomy in people with Localized Prostate Cancer, run by PROCEPT BioRobotics at 37 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, United Kingdom, Canada, Germany, Hong Kong and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pad use for urinary incontinence (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.