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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05438563
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • MRI-Guided Transurethral Ultrasound Ablation — PROCEDURE
    Undergo MRI-Guided TULSA
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Digital Rectal Examination — PROCEDURE
    Undergo DRE
  • Cystoscopy — PROCEDURE
    Undergo cystoscopy
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • PSMA PET Scan — PROCEDURE
    Undergo PSMA PET
  • Multiparametric Magnetic Resonance Imaging — PROCEDURE
    Undergo mpMRI

Study Details

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.

Key Dates

Start date
Apr 6, 2022
Status verified
Sep 2025
Primary completion
Mar 7, 2027
Completion
Mar 7, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (MRI-guided TULSA)
    Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.

Primary Outcome Measure

Proportion of patients free from treatment failure [ Time Frame: At 24 months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trial Referral Office
[email protected]
855-776-0015
David A. Woodrum, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Mayo Clinic in Rochester· Rochester, MN

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