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FDA Poised To OK Biotech New Procedure For Prostate Cancer

FDA poised to OK biotech new procedure for prostate cancer
A nonsurgical, outpatient treatment for prostate cancer, with a low rate of side effects, is poised for approval by the U.S. Food and Drug Administration within the next few weeks.
Treatment with high-intensity focused ultrasound (HIFU) waves use heat focused at a specific location to destroy the area of the prostate gland affected with cancer, while any tissue outside of the focal point remains unharmed.
“The oncological results for HIFU are broadly comparable to radical surgery or radiation but the side effects are less,” said Dr. Michael Lazar, a urology specialist in Santa Rosa.
HIFU is most effective for patients with early stage prostate cancer where the cancer is localized to the prostate. The procedure preserves healthy tissue and preserving nerves, urine flow and erectile function in about 80 percent of cases compared to 40 percent–50 percent with surgery or radiation.
HIFU is also performed on an out-patient basis, taking one to four hours. A urinary catheter is inserted after the procedure and must be kept in place for one to three weeks. The most common side effects are infections in the prostate area, and incontinence, to a lesser degree than other therapies.

Another advantage is recovery time. With surgery or radiation treatment, recuperation time for patients is six to eight weeks.
“If the HIFU procedure is performed in the morning, a patient is typically up and around by dinnertime and can often return to normal activity within a few days without the use of pain-killers,” Lazar said.
Combined with the less invasive technique, quicker recovery rate, and reduced side effects, the procedure is likely to be favored over current treatment options, said Dr. Eugene Rajaratnam, a urologist in Lancaster who studied the procedure in Germany and has sent patients to Canada and Germany to have it done.
“Once HIFU gets approved (by the FDA), the surgical volume will drastically go down,” he said.
HIFU treatment has been available in other countries for years. Lazar first learned about it in 2007, and began bringing U.S. patients to Toronto, then to Mexico. Since then, he has performed more than 200 of the procedures. Lazar has been traveling to Puerto Vallarta once a month for about seven years, performing outpatient procedures at a U.S. Joint Commission approved bilingual hospital. He is one of five doctors in the U.S. credentialed to perform the procedure, and also serves as a HIFU instructor to other physicians.

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