WATER IV Prostate 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.

Conditions

Localized Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

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

WATER IV Prostate Cancer

Condition
Localized Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Chandler

Arizona State Urological Institute, Chandler, Arizona, United States, 85224

Mesa

East Valley Urology Center, Mesa, Arizona, United States, 85206

Los Angeles

University of Southern California, Los Angeles, California, United States, 90089

Boulder

Boulder Medical Center, Boulder, Colorado, United States, 80304

Tampa

Florida Urology Partners, Tampa, Florida, United States, 33606

Atlanta

Georgia Urology, Atlanta, Georgia, United States, 30328

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Glenview

Endeavor Health, Glenview, Illinois, United States, 60026

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66103

North Kansas City

Kansas City Urology Care, North Kansas City, Missouri, United States, 64116

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Biological male with age ≥ 45 years at the time of consent
  • 2. Biopsy positive Grade Group 1-3 prostate cancer
  • 3. Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment.
  • 4. Clinical Stage ≤ T2c
  • 5. PSA ≤ 20 ng/ml
  • 6. Prostate volume ≥25 ml
  • 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. Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.
  • 3. Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.
  • 4. Patient is unwilling to accept a blood transfusion if required.
  • 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. 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.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

PROCEPT BioRobotics,

Study Record Dates

2037-01