Actively Recruiting
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
Led by Mayo Clinic · Updated on 2025-09-09
100
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with low to intermediate grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.
CONDITIONS
Official Title
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male
- Age 45 to 80 years with more than 10 years life expectancy
- Biopsy-confirmed low to intermediate risk prostate cancer (Gleason Grade 1, favorable Grade 2, or unfavorable Grade 3)
- Cancer stage T2c or lower, with no lymph node (N0) or distant metastasis (M0)
- ISUP grade group 1, 2, or 3 disease confirmed by biopsy within 12 months
- PSA level 20 ng/mL or below within 3 months of baseline
- No prior treatment for prostate cancer
- Planned ablation volume less than 3.0 cm axial radius from urethra on recent mpMRI
You will not qualify if you...
- Unable to undergo MRI or general anesthesia
- Tumor located more than 30 mm or less than 14 mm from the prostatic urethra
- Prostate calcifications larger than 3 mm blocking tumor ablation
- Unresolved urinary tract infection or prostatitis
- History of proctitis, bladder stones, hematuria, acute urinary retention, or severe neurogenic bladder
- Presence of artificial urinary sphincter, penile implant, or intraprostatic implant
- Life expectancy less than 10 years
- Not a candidate for radical prostatectomy
- Unable or unwilling to give informed consent
- History of anal or rectal fibrosis or stenosis, urethral stenosis, or other issues preventing device insertion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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