RecruitingNot ApplicableNCT04808427

Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer

Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation


Sponsor

National Cancer Institute (NCI)

Enrollment

21 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Background: The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods. Objective: To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer. Eligibility: English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation. Design: Participants will be screened with the following: * Medical history * Physical exam * Digital rectal exam * Blood and urine tests * Electrocardiogram * Tumor biopsy * Questionnaire to assess urinary tract symptoms * MRI of the pelvis. The MRI scanner is a long, narrow tube. Participants will lie on a bed that moves in and out of the scanner. Participants may also be screened with the following: * Echocardiogram * Chest x-ray * Bone scan * Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine * MRI of the brain * Transrectal ultrasound * Computer tomography (CT) scan of the chest, abdomen, and pelvis. A CT scan is a series of x-ray images taken of parts of the body. Some screening tests will be repeated during the study. Participants will have the TULSA procedure. They will have an MRI for guidance. A small ultrasound applicator will be placed into their urethra. It uses heat to destroy the cancer areas in the prostate. It is controlled by a robotic arm. A cooling catheter will be placed into their rectum. Participants will use a urethral catheter for 1-7 days. Participants will have follow-up visits at 3, 6, 12, 18, 24, and 36 months.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an MRI-guided ultrasound ablation (using focused sound waves to destroy tissue) as a targeted treatment for prostate cancer, to see if it can effectively treat the cancer with fewer side effects than standard whole-gland treatments like surgery or full radiation. **You may be eligible if...** - You have prostate cancer diagnosed by biopsy - Your cancer is Gleason score 7 or lower (low to intermediate risk) - Your cancer is visible or trackable on MRI - You are willing to undergo the procedure at the study site (NIH/NCI) **You may NOT be eligible if...** - Your Gleason score is 8 or higher - Your cancer is not visible on MRI - You have had prior prostate treatment - You have conditions that prevent safe MRI or ultrasound procedures 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

DEVICETULSA-PRO

Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04808427


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