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Washington, D.C. — John Lynch, M.D., Chief of Urology at Georgetown University Medical Center, has conducted the first prostate cancer treatments in the United States using Ablatherm, a high-intensity focused ultrasound device. Ablatherm offers a new minimally invasive approach for treating localized prostate cancer with limited effects on surrounding tissue.
Dr. Lynch conducted the two treatments in July as part of a clinical trial under an investigational device exemption (IDE) from the U.S. Food and Drug Administration granted to EDAP Technomed, Inc., the manufacturer of Ablatherm. Georgetown is the first of three U.S. sites to treat patients in the IDE study, which is slated to include 120 prostate cancer patients who already have been treated with radiation but have experienced a recurrence of the disease. The other sites are Baylor University and the University of California at San Francisco.
"Ablatherm holds great promise as a method to treat localized prostate cancer with a minimum of side effects," Dr. Lynch said. "The commencement of U.S. trials is a big step toward bringing this unique, minimally invasive tool into the treatment mainstream for the large number of American men who suffer from prostate cancer."
The Ablatherm technology is designed to destroy tumors by delivering high-intensity focused ultrasound (HIFU) transrectally to the tumor site. Ablatherm treatment generally is conducted on an outpatient basis under spinal anesthesia. The Ablatherm device uses high-powered acoustic transducers to produce focused ultrasound waves that quickly generate high-temperature heat in precise volumes. The application of HIFU is accompanied by rectal wall cooling and distance control, thereby allowing for the destruction of lesions within the prostate capsule with minimal risk of damage to adjacent tissue.
The device already has been use to treat more than 30 patients in a multicenter study in Europe. One-year follow-up data on 247 patients treated in the European study recently was presented at the European Association of Urology annual meeting. The data demonstrate an 85 percent one-year success rate for the patient population, which includes patients with local disease, local progression after failed therapy, and primary metastatic disease treated in combination with hormonal therapy.
Approximately 190,000 new cases of prostate cancer are projected to be diagnosed this year, and approximately 37,000 deaths are expected.
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