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

Summary

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

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

Interventions

PROCEDURE

MRI-Guided Transurethral Ultrasound Ablation

Undergo MRI-Guided TULSA

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Digital Rectal Examination

Undergo DRE

PROCEDURE

Cystoscopy

Undergo cystoscopy

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

PSMA PET Scan

Undergo PSMA PET

PROCEDURE

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-06

Primary Completion

2027-03-07

Completion

2027-03-07

Countries

• United States

Study Locations