Phase
Condition
Prostate Disorders
Prostate Cancer
Urologic Cancer
Treatment
Radical Prostatectomy
Aquablation Therapy
Clinical Study ID
Ages > 45 Male
Study Summary
Eligibility Criteria
Inclusion
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 alreadyselected a radical therapy as their treatment.
Clinical Stage ≤ T2c
PSA ≤ 20 ng/ml
Prostate volume ≥25 ml
Exclusion
Exclusion Criteria:
Any prior or current local or systemic treatment for prostate cancer, including butnot limited to surgery, radiation therapy (external or brachytherapy), tissueablation, hormone therapy or chemotherapy.
Patients with previous surgical or minimally invasive treatment of benign prostatichyperplasia within the prior 3 months of study treatment.
Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicleinvasion.
Patient is unwilling to accept a blood transfusion if required.
Any condition or history of illness or surgery that may pose an additional risk topatients 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 Design
Connect with a study center
University of Toronto
Toronto, Ontario M5S3H2
CanadaSite Not Available
University of Toronto
Toronto 6167865, Ontario 6093943 M5S3H2
CanadaActive - Recruiting
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec H2X 0A9
CanadaSite Not Available
Centre Hospitalier de l'Université de Montréal
Montreal 6077243, Quebec 6115047 H2X 0A9
CanadaActive - Recruiting
Clinique Pasteur
Toulouse,
FranceSite Not Available
Clinique Pasteur
Toulouse 2972315,
FranceSite Not Available
Universitätsklinikum OWL der Universität Bielefeld
Bielefeld,
GermanySite Not Available
Universitätsklinikum OWL der Universität Bielefeld
Bielefeld 2949186,
GermanyActive - Recruiting
Chinese University of Hong Kong
Shatin,
Hong KongSite Not Available
Chinese University of Hong Kong
Shatin 1818920,
Hong KongActive - Recruiting
Hospital Cruz Vermelha
Lisbon, 1549-008
PortugalSite Not Available
Hospital Cruz Vermelha
Lisbon 2267057, 1549-008
PortugalSite Not Available
National Taiwan University Hospital
Taipei,
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 1668341,
TaiwanSite Not Available
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hamsphire RG24 7A
United KingdomSite Not Available
Hampshire Hospitals NHS Foundation Trust
Basingstoke 2656192, Hamsphire RG24 7A
United KingdomActive - Recruiting
University of Hertfordshire
Hatfield, Hertfordshire AL10 9AB
United KingdomSite Not Available
University of Hertfordshire
Hatfield 2647349, Hertfordshire AL10 9AB
United KingdomSite Not Available
Norfolk & Norwich University Hospital
Colney, Norwich NR4 7UY
United KingdomSite Not Available
Norfolk & Norwich University Hospital
Colney 2652540, Norwich NR4 7UY
United KingdomActive - Recruiting
Guy's Hospital
London, SE1 9RT
United KingdomSite Not Available
The Royal Marsden Hospital
London, SW3 6JJ
United KingdomSite Not Available
Guy's Hospital
London 2643743, SE1 9RT
United KingdomActive - Recruiting
Royal Free Hospital
London 2643743,
United KingdomActive - Recruiting
The Royal Marsden Hospital
London 2643743, SW3 6JJ
United KingdomActive - Recruiting
Arizona State Urological Institute
Chandler, Arizona 85224
United StatesSite Not Available
East Valley Urological Center
Mesa, Arizona 85206
United StatesSite Not Available
East Valley Urology Center
Mesa, Arizona 85206
United StatesSite Not Available
Arizona State Urological Institute
Chandler 5289282, Arizona 5551752 85224
United StatesActive - Recruiting
East Valley Urology Center
Mesa 5304391, Arizona 5551752 85206
United StatesActive - Recruiting
University of Southern California
Los Angeles, California 90089
United StatesSite Not Available
University of Southern California
Los Angeles 5368361, California 5332921 90089
United StatesActive - Recruiting
Boulder Medical Center
Boulder, Colorado 80304
United StatesSite Not Available
Boulder Medical Center
Boulder 5574991, Colorado 5417618 80304
United StatesActive - Recruiting
Advanced Research
Delray Beach, Florida 33484
United StatesSite Not Available
University of Miami
Miami, Florida 33146
United StatesSite Not Available
Florida Urology Partners
Tampa, Florida 33606
United StatesSite Not Available
Advanced Research
Delray Beach 4153132, Florida 4155751 33484
United StatesActive - Recruiting
University of Miami
Miami 4164138, Florida 4155751 33146
United StatesActive - Recruiting
Florida Urology Partners
Tampa 4174757, Florida 4155751 33606
United StatesActive - Recruiting
Trophy Point Urology
Tampa 4174757, Florida 4155751 33607
United StatesActive - Recruiting
Georgia Urology
Atlanta, Georgia 30328
United StatesSite Not Available
Georgia Urology
Atlanta 4180439, Georgia 4197000 30328
United StatesActive - Recruiting
Mountain View Hospital
Idaho Falls 5596475, Idaho 5596512 83401
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Endeavor Health
Glenview, Illinois 60026
United StatesSite Not Available
University of Chicago
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
Endeavor Health
Glenview 4893886, Illinois 4896861 60026
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66103
United StatesSite Not Available
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66103
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans 4335045, Louisiana 4331987 70121
United StatesSite Not Available
Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
Kansas City Urology Care
North Kansas City, Missouri 64116
United StatesSite Not Available
Kansas City Urology Care
North Kansas City 4400860, Missouri 4398678 64116
United StatesActive - Recruiting
Kearney Urology Center
Kearney, Nebraska 68847
United StatesSite Not Available
Adult & Pediatric Urology
Omaha, Nebraska 68114
United StatesSite Not Available
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska 68114
United StatesSite Not Available
Kearney Urology Center
Kearney 5071348, Nebraska 5073708 68847
United StatesActive - Recruiting
Adult & Pediatric Urology
Omaha 5074472, Nebraska 5073708 68114
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Northwell Health
New York, New York 10075
United StatesSite Not Available
Solaris Health
New York, New York 10016
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York City, New York 10029
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Integrated Medical Professionals, PLLC
New York 5128581, New York 5128638 10016
United StatesActive - Recruiting
Solaris Health
New York 5128581, New York 5128638 10016
United StatesSite Not Available
University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642
United StatesActive - Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111
United StatesSite Not Available
MUSC
Charleston, South Carolina 29425
United StatesSite Not Available
MUSC
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Urology Associates PC
Nashville, Tennessee 37209
United StatesSite Not Available
Urology Associates PC
Nashville 4644585, Tennessee 4662168 37209
United StatesSite Not Available
Urology Austin
Austin, Texas 78745
United StatesSite Not Available
Objective Health
Dallas, Texas 76017
United StatesSite Not Available
Urology Clinics of North Texas
Dallas, Texas 75231
United StatesSite Not Available
Urology Austin
Austin 4671654, Texas 4736286 78745
United StatesActive - Recruiting
Urology Clinics of North Texas
Dallas 4684888, Texas 4736286 75231
United StatesActive - Recruiting
Potomac Urology
Alexandria, Virginia 22311
United StatesSite Not Available
Potomac Urology
Alexandria 4744091, Virginia 6254928 22311
United StatesActive - Recruiting
Swedish Medical Center
Seattle, Washington 98104
United StatesSite Not Available
Swedish Medical Center
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available
Advocate Aurora Research Institute
Sheboygan, Wisconsin 53081
United StatesSite Not Available
Advocate Aurora Research Institute
Sheboygan 5272893, Wisconsin 5279468 53081
United StatesActive - Recruiting

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