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MRI-guided TULSA for Low to Intermediate Grade Prostate Cancer

This study is testing a procedure called MRI-guided transurethral ultrasound ablation (TULSA) for men with low to intermediate grade prostate cancer. TULSA is a minimally invasive procedure that uses an ultrasound device, guided by MRI imaging, to destroy cancer cells with high-energy sound waves. The goal is to see if TULSA is safe and effective, potentially helping patients avoid surgery and improve their quality of life. The study aims to enroll 100 men between 45 and 80 years old with specific types of prostate cancer. Success will be measured by how many patients are free from treatment failure after 24 months, and how many maintain urinary control and erectile function after 12 months. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 100 male participants. It is testing the MRI-guided TULSA procedure.
What's involved
You would undergo the MRI-guided TULSA procedure. You may also have digital rectal exams (DRE), cystoscopy, biopsies, and other scans. You will be followed for 24 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed at 3, 6, 9, 12, 15, 18, 21, and 24 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05438563

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

Recruiting
NAAges 45–80InterventionalTreatment
Mayo Clinic
~100 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:MRI-Guided Transurethral Ultrasound AblationQuestionnaire AdministrationDigital Rectal ExaminationCystoscopyBiopsyBone Scan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients free from treatment failure
Measured over At 24 months post-treatment
+1 more outcome measured

Conditions

Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • David A Woodrum, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Proportion of patients free from treatment failureAt 24 months post-treatment

    Failure is defined as: delivery of any additional intervention for prostate cancer (local or systemic, including adjuvant therapy); or metastatic disease; or prostate cancer-specific death.

  • Proportion of patients who maintain both urinary continence and erectile potencyAt 12 months

    Continence is defined as 'pad-free' (0 pads/day), and potency is defined as erection firmness sufficient for penetration (Expanded Prostate Cancer Index Composite \[EPIC\]). Two-sided, 95% Pearson-Clopper confidence interval (CI) will be calculated for each intervention arm separately, and the difference in safety outcomes, along with exact 95% two-sided CI will be calculated.