A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer
NCT ID: NCT05027477
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
201 participants
INTERVENTIONAL
2021-11-01
2036-08-31
Brief Summary
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Detailed Description
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Targeted ablation of localized prostate cancer using MRI-guided technology is becoming a favorable option for many men who wish to have their cancer treated but do not wish to compromise their urinary and sexual functions. The TULSA Procedure is a new, minimally-invasive technique that uses real-time MRI-guided technology to guide the delivery of high-energy ultrasound to precisely, and in a customized fashion specific to you, heat and kill the prostate cancer tissue while protecting important surrounding body parts that are important for preserving urinary and sexual function. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like traditional surgery or minimally invasive surgery.
The purpose of this research study is to:
* Test whether the TULSA Study Procedure preserves or improves your quality of life (urinary, bowel and sexual functions) at 12 months post-study treatment compared to standard of care (radical prostatectomy).
* Test how many subjects who undergo the TULSA Study Procedure are free from treatment failure by 3 years post-study treatment compared to subjects who undergo the standard of care (radical prostatectomy). Treatment failure is defined as undergoing other additional prostate cancer treatments, spreading of cancer or death caused by cancer.
About 201 subjects will participate in this study with 67 randomly assigned to the radical prostatectomy group and 134 randomly assigned to the TULSA procedure group. Patients will have a 1 in 3 chance of being assigned to the radical prostatectomy group and a 2 in 3 chance of being assigned to the TULSA group. Following treatment, patients will be followed up for 10 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radical Prostatectomy
Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group.
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
Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 40 to 80 years, with \>10 years life expectancy
* NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months
* Stage ≤cT2c, N0, M0
* ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
* PSA ≤20ng/mL within last 3 months
* Treatment-naïve
* Planned ablation volume is \< 3 cm axial radius from urethra on mpMRI acquired within last 6 months
Exclusion Criteria
* Suspected tumor is \> 30 mm from the prostatic urethra
* Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor
* Unresolved urinary tract infection or prostatitis
* History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
* Artificial urinary sphincter, penile implant, or intraprostatic implant
* Patients who are otherwise not deemed candidates for radical prostatectomy
* Inability or unwillingness to provide informed consent
* History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
40 Years
80 Years
MALE
No
Sponsors
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Profound Medical Inc.
OTHER
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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GCP-10296
Identifier Type: -
Identifier Source: org_study_id
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