WATER IV PCa (AS Sub-study)

NCT07650448 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CSP0005 - AS Sub-study
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Localized Prostate Cancer

Keywords

Aquablation; AquaBeam; HYDROS; Active Surveillance; Prostate Cancer; Aquablation Therapy

Outcome Measures

Primary Outcomes (1)

• Freedom from GG ≥ 2

  12 Months

Secondary Outcomes (1)

• Freedom from persistent or increased MRI suspicion AND additional prostate cancer treatment

  3 Years

Study Arms (2)

Aquablation Therapy

EXPERIMENTAL

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

Device: Aquablation Therapy

Active Surveillance

ACTIVE COMPARATOR

The active surveillance arm will receive standard-of-care for prostate cancer management.

Other: Active Surveillance

Interventions

Aquablation Therapy 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.

Aquablation Therapy

Active Surveillance OTHER

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.

Active Surveillance

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• a. 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.
• \. 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).
• \. 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).

Sponsors & Collaborators

• PROCEPT BioRobotics: lead

Study Sites (17)

Arizona State Urological Institute

Chandler, Arizona, 85224, United States

Location

University of Southern California

Los Angeles, California, 90089, United States

Location

Boulder Medical Center

Boulder, Colorado, 80304, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

Georgia Urology

Atlanta, Georgia, 30328, United States

Location

Mountain View Hospital

Idaho Falls, Idaho, 83401, United States

Location

Endeavor Health

Glenview, Illinois, 60026, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Kansas City Urology Care

North Kansas City, Missouri, 64116, United States

Location

Kearney Urology Center

Kearney, Nebraska, 68847, United States

Location

Adult & Pediatric Urology

Omaha, Nebraska, 68114, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MUSC Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Tidelands Health Urology

Murrells Inlet, South Carolina, 29576, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Advocate Aurora Research Institute

Sheboygan, Wisconsin, 53081, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Angela Lee

CONTACT

650-232-7215; a.lee@procept-biorobotics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study participants will be randomized to either Aquablation or Active Surveillance.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2038
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

US (17)