Phase
Condition
Prostate Disorders
Prostate Cancer, Early, Recurrent
Prostate 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 orunwilling or unable to follow study instructions including randomization andcomplete all required study visits through 10 years. This includes individuals withsevere cognitive disabilities, those under legal guardianship, or those currentlyincarcerated.
Patient currently participating in other studies unless approved by Sponsor inwriting.
Study Design
Connect with a study center
University of Toronto
Toronto, Ontario M5S3H2
CanadaSite Not Available
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec H2X 0A9
CanadaSite Not Available
Clinique Pasteur
Toulouse,
FranceSite Not Available
Universitätsklinikum OWL der Universität Bielefeld
Bielefeld,
GermanySite Not Available
Chinese University of Hong Kong
Shatin,
Hong KongSite Not Available
Hospital Cruz Vermelha
Lisbon, 1549-008
PortugalSite Not Available
National Taiwan University Hospital
Taipei,
TaiwanSite Not Available
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hamsphire RG24 7A
United KingdomSite Not Available
University of Hertfordshire
Hatfield, Hertfordshire AL10 9AB
United KingdomSite Not Available
Norfolk & Norwich University Hospital
Colney, Norwich NR4 7UY
United KingdomSite Not Available
Guy's Hospital
London, SE1 9RT
United KingdomSite Not Available
The Royal Marsden Hospital
London, SW3 6JJ
United KingdomSite Not Available
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 StatesActive - Recruiting
University of Southern California
Los Angeles, California 90089
United StatesSite Not Available
Boulder Medical Center
Boulder, Colorado 80304
United StatesSite Not Available
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
Georgia Urology
Atlanta, Georgia 30328
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Endeavor Health
Glenview, Illinois 60026
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66103
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Kansas City Urology Care
North Kansas City, Missouri 64116
United StatesSite Not Available
Kearney Urology Center
Kearney, Nebraska 68847
United StatesActive - Recruiting
Adult & Pediatric Urology
Omaha, Nebraska 68114
United StatesActive - Recruiting
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska 68114
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
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
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
MUSC
Charleston, South Carolina 29425
United StatesSite Not Available
Urology Associates PC
Nashville, Tennessee 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
Potomac Urology
Alexandria, Virginia 22311
United StatesActive - Recruiting
Swedish Medical Center
Seattle, Washington 98104
United StatesSite Not Available
Advocate Aurora Research Institute
Sheboygan, Wisconsin 53081
United StatesSite Not Available
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