A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT05027477

Run by

Profound Medical Inc.

People needed

201

Starts

2021-11-01

Expected to finish

2036-08-31

Last updated by the study team

2025-08-17

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male
• 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

You may not qualify if…

• Inability to undergo MRI or general anesthesia
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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