Clinical trial NCT06651632: WATER IV Prostate Cancer
Official title: WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Localized Prostate Cancer
Keywords: Aquablation therapy
Aquablation
Prostate cancer
AQUABEAM
radical prostatectomy
HYDROS
Lead sponsor: PROCEPT BioRobotics
Sponsor class: INDUSTRY
First posted: 2024-10-22
Enrollment: 280
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Rate of pad use for urinary incontinence
timeFrame: 6 Months
measure: Rate of erectile dysfunction
timeFrame: 6 Months
Secondary outcomes:
measure: Rate of pad use for urinary incontinence
timeFrame: 3 Months
measure: Rate of erectile dysfunction
timeFrame: 3 Months
measure: Stable or improved Grade Group at 1 year compared to baseline (Aquablation arm only)
timeFrame: 1 Year
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona State Urological Institute
state: Arizona
city: Mesa
country: United States
facility: East Valley Urology Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Boulder
country: United States
facility: Boulder Medical Center
state: Colorado
city: Delray Beach
country: United States
facility: Advanced Research
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Atlanta
country: United States
facility: Georgia Urology
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Glenview
country: United States
facility: Endeavor Health
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: North Kansas City
country: United States
facility: Kansas City Urology Care
state: Missouri
city: Kearney
country: United States
facility: Kearney Urology Center
state: Nebraska
city: Omaha
country: United States
facility: Adult & Pediatric Urology
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Solaris Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates PC
state: Tennessee
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Alexandria
country: United States
facility: Potomac Urology
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Sheboygan
country: United States
facility: Advocate Aurora Research Institute
state: Wisconsin
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bielefeld
country: Germany
facility: Universitätsklinikum OWL der Universität Bielefeld
city: Shatin
country: Hong Kong
facility: Chinese University of Hong Kong
city: Lisbon
country: Portugal
facility: Hospital Cruz Vermelha
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
state: Hamsphire
city: Hatfield
country: United Kingdom
facility: University of Hertfordshire
state: Hertfordshire
city: Colney
country: United Kingdom
facility: Norfolk & Norwich University Hospital
state: Norwich
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
References: