AUA 2016: Questions Remain About HIFU Use After The FDA Weighs In on Behalf of Ablation vs. Treatment -

Twice, over more than a decade, the Food and Drug Administration rejected use of high intensity focused ultrasound for the treatment of prostate cancer. In October of 2015, the FDA granted approval for the procedure for general ablation—not treatment—of prostatic tissue, reflecting a change in attitude that has occurred almost a decade and a half during which the two companies producing the technology have sought FDA approval. 

Over time, the medical community came to judge that perhaps too many men who didn’t need treatment were receiving it. And, said Michael O. Koch, MD, Chair of the Department of Urology at Indiana University School of Medicine and moderator of a Late-Breaking panel session at the American Urological Association’s 2016 meeting, in San Diego, CA, there is the philosophy that there is no need to treat the entire prostate. Dr. Koch’s comments, made at the AUA’s annual meeting, May 6-10, in San Diego were reported in the AUA Daily News.

HIFU technology has been in regular use for a number of years in parts of Europe and Canada for the treatment of prostate cancer.  In the U.S, however, it remains unclear how HIFU is going to be used—whether to treat the entire prostate; whether it is appropriate to treat radiation failures, and/or to treat part of the prostate.

Some experts believe that HIFU may be most appropriate for partial treatment of a prostate tumor that is confined to one part of the gland, in order to avoid side effects such as incontinence and impotence that may accompany surgery or radiation.

One school of thought is that HIFU may be an appropriate alternative to active surveillance for T1 or T2 tumors and Gleason scores of 6 or less. Dr. Koch disagrees with this thinking. “If it is safe to just monitor people, then I think they should just be monitored”, he said.

That insurers balk at coverage of the procedure, is another issue—a consequence of the FDA’s granting its approval for “ablation” rather than “treatment” Patients are sometimes willing to pay cash for HIFU treatment, but members of the medical community think that this may change. HIFU treatment can be more cost-effective than radiation or surgery.

The two companies produce HIFU technology: SonaCare Medical, with the Sonablast 450; and the French company, EDAP TMS, that is familiar to clinicians for its Ablatherm technology.

One shortcoming of HIFU is false-negative results, from MRI images and repeated biopsies to ascertain the location of disease. And, as yet, the impact of HIFU survival is unknown.


Written by: Barbara Jones for UroToday eat the AUA 2016, San Diego, CA.