Localized Prostate CancerNCT07650448
WATER IV PCa (AS Sub-study)
A study testing Aquablation Therapy and Active Surveillance in people with Localized Prostate Cancer, run by PROCEPT BioRobotics at 25 sites in 2 countries.
Trial summary
The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer. 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 Active Surveillance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Sep 2026to Dec 2038
- 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 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3)
- First prostate cancer diagnoses within 18 months (545 days) of consent
- Are candidates for active surveillance
- Clinical Stage ≤ T2c
- PSA < 15 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).
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- 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).
Trial locations and contacts
25 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 2 countries
United States24 sites
Albany Medical College
Albany, New York, 12208
Georgia Urology
Atlanta, Georgia, 30328
Urology Austin
Austin, Texas, 78745
Johns Hopkins University
Baltimore, Maryland, 21287
Boulder Medical Center
Boulder, Colorado, 80304
Arizona Clinical Trials
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
University of Miami
Miami, Florida, 33146
Tidelands Health Urology
Murrells Inlet, South Carolina, 29576
Tri Valley Urology
Murrieta, California, 92562
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
About this study
Official title: WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer
The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.
Read the detailed description
The WATER IV AS sub-study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with low to intermediate risk localized prostate cancer who are candidates for active surveillance. Participants will be randomized to either Aquablation Therapy or active surveillance and followed up to 10 years.
- Conditions
- Localized Prostate Cancer
- Being tested
- Aquablation Therapy, Active Surveillance
- Keywords
- Aquablation, AquaBeam, HYDROS, Active Surveillance, Prostate Cancer, Aquablation Therapy
- 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.
Active SurveillanceOther
Active surveillance is a management strategy for men with low- and favorable intermediate-risk localized prostate cancer that involves close monitoring with curative intent, reserving treatment for evidence of disease progression. Monitoring typically includes serial PSA testing, periodic prostate MRI, and repeat biopsies at scheduled intervals, with intervention triggered by evidence of disease progression.
| 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 |
| Active Surveillance | Active comparator | The active surveillance arm will receive standard-of-care for prostate cancer management. Receives: Other: Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from GG ≥ 2
Measured: 12 Months
Secondary outcomes (1)
Freedom from persistent or increased MRI suspicion AND additional prostate cancer treatment
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2038 (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
- Model description
- Study participants will be randomized to either Aquablation or Active Surveillance.
- Masking
- None (open label)
- Enrolment
- 333 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
- NCT07650448
- Sponsor's protocol ID
- CSP0005 - AS Sub-study
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2026
- Last updated
- 4 Aug 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07650448
- Acronym / sponsor ID
- CSP0005 - AS Sub-study
- Conditions
- Localized Prostate Cancer
- Keywords
- Aquablation, AquaBeam, HYDROS, Active Surveillance, Prostate Cancer, Aquablation Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- PROCEPT BioRoboticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 16 Jun 2026 (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.
The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.
Detailed description
The WATER IV AS sub-study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with low to intermediate risk localized prostate cancer who are candidates for active surveillance. Participants will be randomized to either Aquablation Therapy or active surveillance 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
- Model description
- Study participants will be randomized to either Aquablation or Active Surveillance.
| 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 |
| Active Surveillance | Active comparator | Other: Active SurveillanceThe active surveillance arm will receive standard-of-care for prostate cancer management. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biological male with age ≥ 45 years at the time of consent
- Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3)
- First prostate cancer diagnoses within 18 months (545 days) of consent
- Are candidates for active surveillance
- Clinical Stage ≤ T2c
Key exclusion criteria (10 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 |
| Active SurveillanceActive surveillance is a management strategy for men with low- and favorable intermediate-risk localized prostate cancer that involves close monitoring with curative intent, reserving treatment for evidence of disease progression. Monitoring typically includes serial PSA testing, periodic prostate MRI, and repeat biopsies at scheduled intervals, with intervention triggered by evidence of disease progression. | Other | Active Surveillance |
Primary outcome
Freedom from GG ≥ 2
Time frame: 12 Months
1 secondary outcome
Freedom from persistent or increased MRI suspicion AND additional prostate cancer treatment
Time frame: 3 Years
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 Aug 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.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquablation Therapy and Active Surveillance in people with Localized Prostate Cancer, run by PROCEPT BioRobotics at 25 sites in 2 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Hong Kong. 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?
Contact Angela Lee (650-232-7215, a.lee@procept-biorobotics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from GG ≥ 2 (time frame: 12 Months). 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 Aug 2026.