Frontlight ResearchEarly access
Taking people in United StatesNo phase
Aquablation Compared With Active Surveillance for Localized Prostate Cancer
Compares Aquablation therapy with active surveillance in men with localized prostate cancer.
Key facts
- Who runs it
- PROCEPT BioRobotics
- Where
- Albany, Alexandria, Atlanta, Austin, Baltimore, Boulder, Chandler, Charleston, Chicago, Cleveland, Dallas, Delray Beach, Glenview, Hackensack, Idaho Falls, Kearney, Los Angeles, Miami, Murrells Inlet, Murrieta, New York, North Kansas City, Omaha, Rochester, Sheboygan, and Tampa, United StatesSee the 27 sitesAlso in 1 other country, 1 site
- Trial code
- Registry title
- WATER IV PCa (AS Sub-study)
- Status
- Recruiting
- People taking part
- 333 people, planned
- Started
- 11 Sept 2026
- Expected to end
- Dec 2038
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Aquablation Therapy
- Active Surveillance
- Record updated
- 6 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with newly found, early prostate cancer that has not spread. It compares Aquablation with active surveillance.
- Age
- 45 years or older
- Sex
- Men only
- Disease stage
- Prostate cancer found by biopsy: Grade Group 2, or Grade Group 1 with a lesion visible on MRI (PI-RADS/Likert ≥ 3). Clinical stage T2c or lower. PSA below 15 ng/ml. Prostate volume of at least 25 ml.
- Earlier treatment
- First prostate cancer diagnosis within 18 months (545 days) before consent. No earlier treatment for prostate cancer.
- Biomarker or test result
- PSA below 15 ng/ml
Main reasons for not taking part
- Any earlier or current treatment for prostate cancer
- Cancer spread to lymph nodes or bone, or growth outside the prostate
- Treatment for benign prostate enlargement in the last 3 months
- Unwilling to accept a blood transfusion if needed
- Cannot give informed consent or cannot follow the study visits through 10 years
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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 take part
- 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
- 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)
- 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
- 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)
- Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion
- Patient is unwilling to accept a blood transfusion if required
- Patient currently participating in other studies unless approved by Sponsor in writing
- 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)
Where in United States
Also in 1 other country, 1 site
- Albany Medical CollegeAlbany, United StatesContact: Brenda RomeoNot yet recruiting
- Potomac UrologyAlexandria, United StatesContact: Zoe GoldsteinNot yet recruiting
- Georgia UrologyAtlanta, United StatesContact: Cyprian AdiTaking people
- Midtown UrologyAustin, United StatesContact: Andrew BargerTaking people
- Urology AustinAustin, United StatesContact: Jennifer Penshorn, RNTaking people
- Johns Hopkins UniversityBaltimore, United StatesContact: George MetriNot yet recruiting
- Boulder Medical CenterBoulder, United StatesContact: Stephanie LeonardNot yet recruiting
- Arizona State Urological InstituteChandler, United StatesContact: Dianna BaldanadoNot yet recruiting
- MUSC Hollings Cancer CenterCharleston, United StatesContact: Sarah HelpinstillTaking people
- University of ChicagoChicago, United StatesContact: Briana HarrisonNot yet recruiting
- Cleveland Clinic FoundationCleveland, United StatesContact: Lauren GrimmNot yet recruiting
- Urology Clinics of North TexasDallas, United StatesContact: Jacquelyn WardTaking people
- Advanced ResearchDelray Beach, United StatesContact: Julia ConceiçãoTaking people
- Endeavor HealthGlenview, United StatesContact: Pooja TalatyTaking people
- Hackensack University Medical CenterHackensack, United StatesContact: Oncology Clinical Research Referral OfficeNot yet recruiting
- Mountain View HospitalIdaho Falls, United StatesContact: Morgann TorresTaking people
- Kearney Urology CenterKearney, United StatesContact: Monique PohlmanTaking people
- University of Southern CaliforniaLos Angeles, United StatesContact: Ileana AldanaTaking people
- University of MiamiMiami, United StatesContact: Laura OchoaNot yet recruiting
- Tidelands Health UrologyMurrells Inlet, United StatesContact: Barbara RoeNot yet recruiting
- Tri Valley UrologyMurrieta, United StatesContact: Anita DeedsNot yet recruiting
- Integrated Medical Professionals, PLLCNew York, United StatesContact: Michael YangTaking people
- Kansas City Urology CareNorth Kansas City, United StatesContact: Judy SearcyNot yet recruiting
- Adult & Pediatric UrologyOmaha, United StatesContact: Christian ValverdeTaking people
- University of Rochester Medical CenterRochester, United StatesContact: Caitlyn MichelsenNot yet recruiting
- Advocate Aurora Research InstituteSheboygan, United StatesContact: Mary TheodoroffNot yet recruiting
- Trophy Point UrologyTampa, United StatesContact: Zachary FinleyNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Aquablation TherapyTreatment being tested
The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System
- Active SurveillanceExisting treatment, for comparison
The active surveillance arm will receive standard-of-care for prostate cancer management.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer
- Plain-language title
- Aquablation Compared With Active Surveillance for Localized Prostate CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 November 2026