Trial Title:
WATER IV Prostate Cancer
NCT ID:
NCT06651632
Condition:
Localized Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Aquablation therapy
Aquablation
Prostate cancer
AQUABEAM
radical prostatectomy
HYDROS
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Aquablation Therapy
Description:
The AquaBeam Robotic System and the HYDROS Robotic System utilize high-velocity sterile
saline waterjet to resect prostate tissue, guided by real-time visualization through
cystoscopy and transrectal ultrasound imaging. This minimally invasive surgical procedure
is called the Aquablation therapy.
Arm group label:
Aquablation Therapy
Intervention type:
Procedure
Intervention name:
Radical Prostatectomy
Description:
Radical prostatectomy is a surgery that is performed through an incision in the lower
abdomen or perineum, or with a laparoscope or robotic system to remove the entire
prostate gland.
Arm group label:
Radical Prostatectomy
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.
Criteria for 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.
Gender:
Male
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California
Address:
City:
Los Angeles
Zip:
90089
Country:
United States
Contact:
Last name:
Ileana Aldana
Facility:
Name:
Georgia Urology
Address:
City:
Atlanta
Zip:
30328
Country:
United States
Contact:
Last name:
Lydia Jordan
Facility:
Name:
Endeavor Health
Address:
City:
Glenview
Zip:
60026
Country:
United States
Contact:
Last name:
Pooja Talaty
Facility:
Name:
University of Kansas Medical Center
Address:
City:
Kansas City
Zip:
66103
Country:
United States
Contact:
Last name:
Laura Mitchell
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York City
Zip:
10029
Country:
United States
Contact:
Last name:
Steven Kaplan, MD
Facility:
Name:
Urology Austin
Address:
City:
Austin
Zip:
78745
Country:
United States
Contact:
Last name:
Brian Mazzarella, MD
Facility:
Name:
Potomac Urology
Address:
City:
Alexandria
Zip:
22311
Country:
United States
Contact:
Last name:
Morgan Gray
Facility:
Name:
University of Toronto
Address:
City:
Toronto
Zip:
M5S3H2
Country:
Canada
Contact:
Last name:
Iris Chan
Facility:
Name:
Centre Hospitalier de l'Université de Montréal
Address:
City:
Montréal
Zip:
H2X 0A9
Country:
Canada
Contact:
Last name:
Abbas Guennoun
Facility:
Name:
Chinese University of Hong Kong
Address:
City:
Shatin
Country:
Hong Kong
Contact:
Last name:
Becky Lau
Facility:
Name:
Hospital Cruz Vermelha
Address:
City:
Lisbon
Zip:
1549-008
Country:
Portugal
Contact:
Last name:
Tiago Rodrigues, MD
Facility:
Name:
Norfolk & Norwich University Hospital
Address:
City:
Colney
Zip:
NR4 7UY
Country:
United Kingdom
Contact:
Last name:
Claire Hayes
Facility:
Name:
The Royal Marsden Hospital
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Contact:
Last name:
Reyhaneh SadeghZadeh
Start date:
January 2025
Completion date:
January 2037
Lead sponsor:
Agency:
PROCEPT BioRobotics
Agency class:
Industry
Source:
PROCEPT BioRobotics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06651632
