WATER IV PCa (AS Sub-study)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
PROCEPT BioRobotics
Study ID
NCT07650448
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Localized Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2038

Study Design

Enrollment
333 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aquablation Therapy
    The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System
  • Active Comparator: Active Surveillance
    The active surveillance arm will receive standard-of-care for prostate cancer management.

Primary Outcome Measure

Freedom from GG ≥ 2 [ Time Frame: 12 Months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Arizona State Urological InstituteChandlerArizona85224-
University of Southern CaliforniaLos AngelesCalifornia90089-
Boulder Medical CenterBoulderColorado80304-
University of MiamiMiamiFlorida33146-
Georgia UrologyAtlantaGeorgia30328-
Mountain View HospitalIdaho FallsIdaho83401-
Endeavor HealthGlenviewIllinois60026-
Johns Hopkins UniversityBaltimoreMaryland21287-
Kansas City Urology CareNorth Kansas CityMissouri64116-
Kearney Urology CenterKearneyNebraska68847-
Adult & Pediatric UrologyOmahaNebraska68114-
Hackensack University Medical CenterHackensackNew Jersey07601-
Cleveland Clinic FoundationClevelandOhio44195-
MUSC Hollings Cancer CenterCharlestonSouth Carolina29425-
Tidelands Health UrologyMurrells InletSouth Carolina29576-
Urology Clinics of North TexasDallasTexas75231-
Advocate Aurora Research InstituteSheboyganWisconsin53081-

Find similar trials in Chandler, AZ

By research site
Arizona State Urological Institute· Chandler, AZUniversity of Southern California· Los Angeles, CABoulder Medical Center· Boulder, COUniversity of Miami· Miami, FLGeorgia Urology· Atlanta, GAMountain View Hospital· Idaho Falls, ID

Related Studies