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WATER IV Prostate Cancer
Trial Status: active
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.
Inclusion Criteria
Biological male with age ≥ 45 years at the time of consent
Biopsy positive Grade Group 1-3 prostate cancer
Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment.
Clinical Stage ≤ T2c
PSA ≤ 20 ng/ml
Prostate volume ≥25 ml
Exclusion Criteria
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.
Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.
Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.
Patient is unwilling to accept a blood transfusion if required.
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).
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.
Patient currently participating in other studies unless approved by Sponsor in
writing.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06651632.
