Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Institutes of Health Clinical Center (CC)
Background: * Pilot study to evaluate the feasibility of real time ultrasound imaging to guide focal thermal ablation of low to intermediate risk focal prostate tumors. * Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years. * 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 that poses little threat to life or health. * An NIH/NCI protocol #11-C-0158 titled MR Image guided focal laser ablation therapy of prostate cancer has treated 15 patients without major complication over the past 5 years. Out of 15 patients, 3 have had evidence of disease recurrence (data from this study was published in Diagnostic and Interventional Radiology). This data are being prepared for publication (verbal communication with Peter Pinto, MD, principal investigator); however, it requires a very long and resource-intensive MRI imaging, which may be a barrier to broad translation to the community setting. Specialized custom and expensive MRI-compatible equipment is also required. Focal laser ablation for prostate cancer using the Tranberg CLS Thermal Therapy System and laser are FDA cleared. * Focal thermal ablation such as laser ablation or cryosurgery are standard of care therapies for prostate cancer, with cancer control comparable to that of external beam radiotherapy and brachytherapy. * NIH / NCI clinical trials have performed MRI + ultrasound (US) fusion biopsy in nearly 3000 patients, \> 40,000 biopsies over the past 18 years. * We propose to perform ultrasound (US) guided focal thermal ablation with fusion visualization and co-display of pre-acquired MRI during the treatment of patients. Objectives: -To determine the feasibility of treating biopsy-confirmed, US-targetable and/or MR-visible, low to intermediate risk prostate tumor(s) using ultrasound (US) image-guided focal interstitial thermal ablation. Eligibility: * Patients must have organ confined, biopsy-confirmed, low or intermediate risk prostate cancer that is either US-targetable or MR visible, or both. * Men \>= 18 years of age. Design: * Pilot study, testing feasibility of ultrasound-guided thermal ablation of focal prostate cancer. * A total of 30 patients will be enrolled to yield 20 evaluable patients
Age
18–100
Sex
MALE
Healthy volunteers
Not accepted
