Who is eligible for clinical trial NCT05438563?

Participants must meet protocol criteria for Prostate Carcinoma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05438563 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-21

MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer (NCT05438563)

🟢 Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: Mayo Clinic

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (12 items).

Location: Mayo Clinic in Rochester — Rochester, Minnesota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check 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).

Male
Age 45-80 years, with \> 10 years life expectancy
Biopsy-confirmed, NCCN \[Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3\] intermediate-risk prostate cancer
Stage =\< T2c, N0, M0
International Society of Urological Pathology (ISUP) grade group 1, 2, or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy \[minimum 3 cores from each Prostate Imaging-Reporting and Data System (PI-RADS) version (v)2 category \>= 3 lesion\]. Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline
Prostate specific antigen (PSA) =\< 20 ng/mL reported within 3 months of baseline
Treatment naive
Planned ablation volume \< 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Inability to undergo MRI or general anaesthesia
Suspected tumour \> 30 mm from the prostatic urethra or \< 14 mm from the prostatic urethra
Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)
Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcification. Imaging for calcification screening must be dated within 1 year of baseline visit
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
Less than 10 years life expectancy
Patients who are otherwise not deemed candidates for radical prostatectomy (RP)
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 (1 Sites)

Mayo Clinic in Rochester — Rochester, Minnesota

💰 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.

🏛️ View Official NIH Record ↗