WATER IV PCa (AS Sub-study)
WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 10 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be randomized to either Aquablation Therapy or active surveillance and followed up to 10 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: 1. Biological male with age ≥ 45 years at the time of consent 2. Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3) 3. First prostate cancer diagnoses within 18 months (545 days) of consent 4. Are candidates for active surveillance 5. Clinical Stage ≤ T2c 6. PSA \< 15 ng/ml 7. Prostate volume ≥25 ml Exclusion Criteria: 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: 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). 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. 8\. 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). 9\. 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).
Study sites (24)
AZ
- Arizona Clinical Trials · Chandler, AZ 85224More trials in Chandler
CA
- University of Southern California · Los Angeles, CA 90089More trials in Los Angeles
- Tri Valley Urology · Murrieta, CA 92562More trials in Murrieta
CO
- Boulder Medical Center · Boulder, CO 80304More trials in Boulder
FL
- Advanced Research · Delray Beach, FL 33484More trials in Delray Beach
- University of Miami · Miami, FL 33146More trials in Miami
GA
- Georgia Urology · Atlanta, GA 30328More trials in Atlanta
ID
- Mountain View Hospital · Idaho Falls, ID 83401More trials in Idaho Falls
IL
- University of Chicago · Chicago, IL 60637More trials in Chicago
- Endeavor Health · Glenview, IL 60026More trials in Glenview
MD
- Johns Hopkins University · Baltimore, MD 21287More trials in Baltimore
MO
- Kansas City Urology Care · North Kansas City, MO 64116More trials in North Kansas City
NE
- Kearney Urology Center · Kearney, NE 68847More trials in Kearney
- Adult & Pediatric Urology · Omaha, NE 68114More trials in Omaha
NJ
- Hackensack University Medical Center · Hackensack, NJ 07601More trials in Hackensack
NY
- Albany Medical College · Albany, NY 12208More trials in Albany
- Integrated Medical Professionals, PLLC · New York, NY 10016More trials in New York
- University of Rochester Medical Center · Rochester, NY 14642More trials in Rochester
OH
- Cleveland Clinic Foundation · Cleveland, OH 44195More trials in Cleveland
SC
- MUSC Hollings Cancer Center · Charleston, SC 29425More trials in Charleston
- Tidelands Health Urology · Murrells Inlet, SC 29576More trials in Murrells Inlet
TX
- Urology Austin · Austin, TX 78745More trials in Austin
- Urology Clinics of North Texas · Dallas, TX 75231More trials in Dallas
WI
- Advocate Aurora Research Institute · Sheboygan, WI 53081More trials in Sheboygan