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

Description

This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with 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

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

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Study Overview

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Study Details

Study overview

This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with 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.

Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System

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

Condition
Prostate Carcinoma
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male
  • * Age 45-80 years, with \> 10 years life expectancy
  • * Biopsy-confirmed, NCCN \[favorable Gleason grade (GG) 2 and unfavorable GG3\] intermediate-risk prostate cancer
  • * Stage =\< T2c, N0, M0
  • * International Society of Urological Pathology (ISUP) grade group 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
  • * 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

Ages Eligible for Study

45 Years to 80 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

David A Woodrum, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2026-03-07