"The groundwork of all happiness is health." - Leigh Hunt

FDA Panel Rejects High-Intensity Focused Ultrasound for Early Prostate Cancer

By Charlie Schmidt

There are some ways to kill prostate cancer cells. Radiation and chemotherapy are essentially the most commonly used. Freezing (cryotherapy) is one other. A French company desired to add heat generated by ultrasound waves to weapons, but an FDA advisory panel said “no.”

A heat technique, called high-intensity focused ultrasound (HIFU), is getting used in lots of countries to treat localized prostate cancer. To administer high-intensity focused ultrasound, a physician inserts an ultrasound probe into the rectum, then focuses a beam of sound waves on the cancerous parts of the gland. Proponents say high-intensity focused ultrasound offers a noninvasive (meaning nonsurgical) solution to goal cancer cells that won't damage the nerves that control a person's erectile function. do

As a part of its standard review process for all recent devices, the FDA convenes a panel of experts whose task it’s Assess available data. On the protection and effectiveness of HIFU for localized prostate cancer.

The panel checked out publications on HIFU within the scientific literature. He also reviewed the outcomes from one. Incomplete clinical trial Comparing high intensity focused ultrasound treatment with cryotherapy for early prostate cancer. (Like HIFU, cryotherapy is a noninvasive treatment.) Known because the US Pivotal Study, the trial began in 2012 but never met its goal of recruiting 205 men for every treatment arm. could do When the trial was canceled earlier this 12 months, only 135 men had been treated with high-intensity focused ultrasound and only 5 men had been treated with cryotherapy.

Unpublished results showed that high-intensity focused ultrasound was not more practical. About one in three prostates treated with HIFU tested positive for cancer in biopsies performed two years after treatment. It also carries the next risk of unwanted side effects, with greater than half of men treated with high-intensity ultrasound experiencing erectile dysfunction, urinary retention, incontinence, or other health problems.

The FDA generally heeds the recommendations of its advisory panels — a robust indication that high-intensity focused ultrasound won't be approved here anytime soon. “In our view, HIFU in this country has reached the end of the line,” says Eric Klein, a panelist on the Cleveland Clinic and chairman of the Gluckman Urological and Kidney Institute. The French company that was searching for the FDA's OK, or one other company, may reapply with more complete or convincing data.

Whether the FDA panel's refusal will affect the provision of high-intensity focused ultrasound outside the U.S. is unknown, Garnick says, adding that other countries base approval of medical treatments, and in some cases availability, on their On your individual terms. “And other potential indications for HIFU in the U.S. are still being studied,” says Garnick.