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

NCT04808427 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-11-26

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

TULSA-PRO

Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Peter A Pinto, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2027-05-01
Completion
2027-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04808427 on ClinicalTrials.gov