RECRUITING

WATER IV Prostate Cancer

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Conditions

Localized Prostate CancerAquablation therapyAquablationProstate cancerAQUABEAMradical prostatectomyHYDROS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer

Quick Facts

Study Start:2025-02-03
Study Completion:2037-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06651632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Biological male with age ≥ 45 years at the time of consent
  2. 2. Biopsy positive Grade Group 1-3 prostate cancer
  3. 3. Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment.
  4. 4. Clinical Stage ≤ T2c
  5. 5. PSA ≤ 20 ng/ml
  6. 6. Prostate volume ≥25 ml
  1. 1. 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.
  2. 2. Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.
  3. 3. Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.
  4. 4. Patient is unwilling to accept a blood transfusion if required.
  5. 5. 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:
  6. 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. 7. Patient currently participating in other studies unless approved by Sponsor in writing.

Contacts and Locations

Study Contact

Angela Lee
CONTACT
650-232-7215
a.lee@procept-biorobotics.com

Study Locations (Sites)

Arizona State Urological Institute
Chandler, Arizona, 85224
United States
East Valley Urology Center
Mesa, Arizona, 85206
United States
University of Southern California
Los Angeles, California, 90089
United States
Boulder Medical Center
Boulder, Colorado, 80304
United States
Florida Urology Partners
Tampa, Florida, 33606
United States
Georgia Urology
Atlanta, Georgia, 30328
United States
University of Chicago
Chicago, Illinois, 60637
United States
Endeavor Health
Glenview, Illinois, 60026
United States
University of Kansas Medical Center
Kansas City, Kansas, 66103
United States
Kansas City Urology Care
North Kansas City, Missouri, 64116
United States
Kearney Urology Center
Kearney, Nebraska, 68847
United States
Adult & Pediatric Urology
Omaha, Nebraska, 68114
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Solaris Health
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Northwell Health
New York, New York, 10075
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Urology Austin
Austin, Texas, 78745
United States
Urology Clinics of North Texas
Dallas, Texas, 75231
United States
Objective Health
Dallas, Texas, 76017
United States
Potomac Urology
Alexandria, Virginia, 22311
United States
Swedish Medical Center
Seattle, Washington, 98104
United States
Advocate Aurora Research Institute
Sheboygan, Wisconsin, 53081
United States

Collaborators and Investigators

Sponsor: PROCEPT BioRobotics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03
Study Completion Date2037-01

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2037-01

Terms related to this study

Keywords Provided by Researchers

  • Aquablation therapy
  • Aquablation
  • Prostate cancer
  • AQUABEAM
  • radical prostatectomy
  • HYDROS

Additional Relevant MeSH Terms

  • Localized Prostate Cancer