RecruitingNot ApplicableNCT05438563

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

Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System


Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

Apr 6, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an MRI-guided ultrasound ablation procedure — using focused sound waves to destroy cancer tissue — as a treatment for low to intermediate risk prostate cancer. The procedure is guided by real-time MRI imaging to precisely target only the cancerous tissue while sparing surrounding healthy tissue. **You may be eligible if:** - You are male, between 45 and 80 years old - You have biopsy-confirmed prostate cancer of low to intermediate risk (Gleason grade group 1, 2, or 3) - Your cancer has not spread beyond the prostate (stage T2c or lower) - Your PSA level is 20 ng/mL or less - You have not yet had any treatment for prostate cancer - Your life expectancy is more than 10 years **You may NOT be eligible if:** - You have already received treatment for prostate cancer - Your cancer is high-risk or has spread beyond the prostate - Your PSA is above 20 ng/mL - You do not meet the biopsy criteria specified in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMRI-Guided Transurethral Ultrasound Ablation

Undergo MRI-Guided TULSA

OTHERQuestionnaire Administration

Ancillary studies

PROCEDUREDigital Rectal Examination

Undergo DRE

PROCEDURECystoscopy

Undergo cystoscopy

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREPSMA PET Scan

Undergo PSMA PET

PROCEDUREMultiparametric Magnetic Resonance Imaging

Undergo mpMRI


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT05438563


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