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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04808427
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TULSA-PRO — DEVICE
    Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate

Study Details

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.

Key Dates

Start date
Nov 20, 2023
Status verified
Jun 2026
Primary completion
May 1, 2027
Completion
Sep 1, 2027

Study Design

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

Arms

  • Experimental: 1/Arm 1
    Ultrasound ablation of focal prostate cancer

Primary Outcome Measure

feasibility and tolerability [ Time Frame: 3, 6, 12, 18, 24, and 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

Find similar trials in Bethesda, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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