The Sperling Prostate Center joins a prestigious group of academic and community medical centers participating in a Phase Three clinical trial of a new prostate cancer focal treatment. Dr. Sperling is the Principal Investigator at our Boca Raton, FL study site.
The treatment under investigation is MRI-guided Focused Ultrasound (MRgFUS), a noninvasive technology for the ablation (destruction) of localized prostate cancer tumors. The trial, “Focal MR-Guided Focused Ultrasound Treatment of Localized Low and Intermediate Risk Prostate Lesions,” will evaluate treatment-related safety and initial effectiveness of a device called the ExAblate system. The sponsor of the trial is InSightec, the ExAblate manufacturer. The MRgFUS procedure uses magnetic resonance imaging to plan the targeted treatment, then to guide “rays” of ultrasound energy precisely to their target where intense heat is generated. Multiple overlapping applications guarantee that the entire lesion is treated, plus an additional margin to assure that no cancer cells have escaped being treated. Previous Phase One and Two trials at international sites demonstrated that MRgFUS is safe and has promising effectiveness. Now, this Phase Three trial will follow patients for initial effectiveness (image-guided biopsy at 6 months), and for safety/side effects (12 months).
All of us at the Sperling Prostate Center are proud and excited to be a study site. Our Center features a state-of-the-art 3 Tesla (3T) magnet that is compatible with the ExAblate system. It produces very high resolution scans used to plan, monitor, and verify treatment. Dr. Sperling is a renowned expert in interpreting prostate MRI scans, as well as the leading pioneer in another MRI-guided treatment, Focal Laser Ablation (FLA).
The study design notes that “focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for low to intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity [side effects].”[i] The current study began in 2010 and is scheduled for completion in 2019. The Sperling Prostate Center is joining other renowned sites committed to excellence and forward thinking in the detection, diagnosis and treatment of prostate cancer. This groundbreaking study is part of a revolution in clinical approaches to prostate cancer therapies, as focal therapy presents an alternative to the risks of prostatectomy and radiation.
To learn more about the MRgFUS clinical trial, and whether you would meet the inclusion criteria, contact Lillian Blanchard at 315-427-8357, or email firstname.lastname@example.org.