Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation
National Cancer Institute (NCI)
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.
Description
Background: Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years. Some prostate cancers prove to be small, low grade, and noninvasive and they appear to pose little risk to the life or health of the host. Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy specimen consistent with an insignificant or "indolent" cancer which poses little threat to life or health. We propose that participants with low volume and low grade disease can be best served with…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
* INCLUSION CRITERIA: Subjects must have prostate cancer amenable for ultrasound ablation defined as: * diagnosed by transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy and targeted biopsy of any MRI-visible or tracked lesions; pathological diagnosis must be confirmed by Laboratory of Pathology, NCI; * Gleason Score \<= 7; * MRI-visible or MRI-tracked prostate cancer. This includes prostate cancer found on targeted biopsy of MRI-visible or MRI-tracked lesion. Histologically positive standard biopsy cores of Grade Group \>= 2 prostate cancer must be from an area overlyin…
Interventions
- DeviceTULSA-PRO
Transurethral MR-Thermometry Guided Ultrasound Ablation of the Prostate
Location
- National Institutes of Health Clinical CenterBethesda, Maryland