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Aquablation therapy for localized prostate cancer

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

NA · PROCEPT BioRobotics · NCT06651632

This study tests if Aquablation Therapy is a safe and effective treatment for men with localized prostate cancer compared to traditional surgery.

Quick facts

PhaseNA
Study typeInterventional
Enrollment280 (estimated)
Ages45 Years and up
SexMale
SponsorPROCEPT BioRobotics (industry)
Drugs / interventionschemotherapy, radiation
Locations39 sites (Chandler, Arizona and 38 other locations)
Trial IDNCT06651632 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of Aquablation Therapy in men with localized prostate cancer who are candidates for prostatectomy. Participants will be randomly assigned to receive either Aquablation Therapy or undergo a radical prostatectomy. The study aims to follow participants for up to 10 years to assess long-term outcomes. It targets men with low to high-risk prostate cancer, providing a comparative analysis of these two treatment options.

Who should consider this trial

Good fit: Ideal candidates are biological males aged 45 and older with biopsy-confirmed Grade Group 1-3 localized prostate cancer who are eligible for prostatectomy.

Not a fit: Patients with prior treatments for prostate cancer or those with advanced disease characteristics such as metastasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a less invasive treatment option for localized prostate cancer, potentially improving patient outcomes and quality of life.

How similar studies have performed: Other studies have shown promise with Aquablation Therapy, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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

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.

Where this trial is running

Chandler, Arizona and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Localized Prostate Cancer, Aquablation therapy, Aquablation, Prostate cancer, AQUABEAM, radical prostatectomy, HYDROS

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.