Actively Recruiting
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
Led by National Cancer Institute (NCI) · Updated on 2025-11-26
21
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male adults 18 years or older
- Diagnosed with prostate cancer suitable for ultrasound ablation confirmed by biopsy
- Gleason Score 7 or less
- Prostate cancer visible or tracked by MRI
- Organ-confined clinical T1c or T2a prostate cancer visible on MRI
- PSA less than 20 ng/ml or PSA greater than 20 with PSA density less than 0.15
- Adequate organ and marrow function including platelets >= 50,000/mcL, hemoglobin >= 8 g/dL, and creatinine clearance or eGFR >= 30 mL/min/1.73 m2
- Able to understand and willing to sign informed consent
- Co-enrolled in NCI protocol 16-C-0010
You will not qualify if you...
- Targeted lesion ablation length over 5 cm or lesion extending more than 3 cm from the urethra
- Target ablation volume greater than 100 ml
- Presence of calcifications blocking ultrasound transmission between urethra and target
- Unable to tolerate MRI (due to pacemaker, claustrophobia, or rectal coil intolerance)
- Acute urinary tract infection
- Lower urinary tract symptoms with IPSS score over 20
- Uncontrolled bleeding disorders or coagulopathies
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
K
Karen K Holcomb
CONTACT
P
Peter A Pinto, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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