Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer (NCT02766543)
Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study
🩺 Plain-English Summary (8th-Grade Level)
A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
Who can join: Review the eligibility criteria below.
Location: University of California Los Angeles — Los Angeles, California
Age range: 45 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- University of California Los Angeles — Los Angeles, California
- Yale Cancer Centre — New Haven, Connecticut
- University of Chicago — Chicago, Illinois
- Indiana University — Indianapolis, Indiana
- Johns Hopkins Medicine — Baltimore, Maryland
- William Beaumont Hospital — Royal Oak, Michigan
- Vanderbilt University Medical Center — Nashville, Tennessee
- University of Texas Southwestern Medical Center — Dallas, Texas
- London Health Sciences Centre — London, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario
- University Hospital of Cologne — Cologne,
- Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology) — Heidelberg,
- Radboud University Medical Center — Nijmegen,
- ResoFus Alomar (Hospital Universitari De Bellvitge) — Barcelona,
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.