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A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer
Sponsor: Profound Medical Inc.
Summary
Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe compared to radical prostatectomy.
Official title: Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)
Key Details
Gender
MALE
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
201
Start Date
2021-11-01
Completion Date
2036-08-31
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
Radical Prostatectomy
If you are in this group, you will get the standard of care treatment used to treat this type of cancer: radical prostatectomy. You will undergo this procedure as per standard clinical practice. A radical prostatectomy is a surgical procedure that removes the prostate gland. This is done by making a surgical incision and removing the prostate gland.
TULSA Procedure
If you are in this group, you will get the TULSA Procedure. The TULSA Procedure is a minimally invasive procedure that uses directional ultrasound to produce very high temperature to ablate (destroy) targeted prostate tissue. The procedure is performed in a MRI suite (the physician can see the prostate at all times throughout the procedure) and uses the TULSA-PRO system to ablate prostate tissue. The procedure combines real-time MRI with robotically-driven directional thermal ultrasound to deliver predictable, physician-prescribed ablation of the prostate. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like in traditional surgery.
Locations (22)
Arizona State Urological Institute
Chandler, Arizona, United States
East Valley Urological Center
Mesa, Arizona, United States
Investigate MD
Scottsdale, Arizona, United States
Atlantic Urology Medical Group
Long Beach, California, United States
Urology Group of Southern California
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Comprehensive Urology Medical Group
Los Angeles, California, United States
Alarcon Urology Center
Montebello, California, United States
Pasadena Urological Medical Group
Pasadena, California, United States
Stanford Cancer Center
Stanford, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Sarasota Memorial Health Care System
Sarasota, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
The Urology Place
San Antonio, Texas, United States
Lawson Health Research Institute, London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Turku University Hospital/TYKS
Turku, Southwest Finland, Finland