A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer (NCT05027477)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (10 items).
Location: Arizona State Urological Institute — Chandler, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (22 Sites)
- Arizona State Urological Institute — Chandler, Arizona
- East Valley Urological Center — Mesa, Arizona
- Investigate MD — Scottsdale, Arizona
- Atlantic Urology Medical Group — Long Beach, California
- Urology Group of Southern California — Los Angeles, California
- University of California, Los Angeles — Los Angeles, California
- Comprehensive Urology Medical Group — Los Angeles, California
- Alarcon Urology Center — Montebello, California
- Pasadena Urological Medical Group — Pasadena, California
- Stanford Cancer Center — Stanford, California
- Yale Cancer Center — New Haven, Connecticut
- Mayo Clinic Jacksonville — Jacksonville, Florida
- Sarasota Memorial Health Care System — Sarasota, Florida
- Indiana University — Indianapolis, Indiana
- Johns Hopkins School of Medicine — Baltimore, Maryland
- Mayo Clinic — Rochester, Minnesota
- Cleveland Clinic — Cleveland, Ohio
- The University of Texas Southwestern Medical Center — Dallas, Texas
- The Urology Place — San Antonio, Texas
- Lawson Health Research Institute, London Health Sciences Centre — London, Ontario
- Sunnybrook Research Institute — Toronto, Ontario
- Turku University Hospital/TYKS — Turku, Southwest Finland
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.