HIFU Treatment for Prostate Cancer ?

October, 2015 (I think)
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Despite FDA approval, HIFU use still unsettled
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After twice rejecting high intensity focused ultrasound (HIFU) for the treatment of prostate cancer, the United States Food and Drug Administration (FDA) approved the procedure for general ablation of prostatic tissue in October. The technology has been used for more than a decade in other places, including Europe and Canada, to treat prostate cancer.

The question now for U.S. urologists is how to incorporate HIFU into the range of established prostate cancer treatments. Several experts will discuss HIFU during a special Late-Breaking Session on Friday titled High Intensity Focused Ultrasound – Hope or Hype? The one-hour session begins at noon in Room 6A in the San Diego Convention Center.

Koch_Michael
Michael O. Koch, MD

“It’s not clear how HIFU is going to be used,” said session moderator Michael O. Koch, MD, Chairman of the Urology Department at Indiana University School of Medicine. “You could treat the entire prostate, it can be used for treating radiation failures and it can be used for treating part of the prostate.”

The two companies that received FDA approval are SonaCare Medical, which developed the Sonablate® 450, and EDAP TMS, a French company known for its Ablatherm® technology. Dr. Koch was a trial investigator for the Sonablate® 450.

In the decade and a half that the companies were working toward FDA approval, Dr. Koch said the philosophy around prostate cancer treatment has shifted.

“We realize we have probably treated too many men who didn’t need it, and there is also the philosophy that we don’t need to treat the entire prostate,” he said.

Dr. Koch said HIFU seems best suited for partial treatment if the tumor is confined to one part of the prostate in order to avoid the side effects that may come with radiation and surgery, including incontinence and impotence.

Friday’s session will include a panel discussion to help urologists identify appropriate patients for HIFU. There is a school of thought, Dr. Koch said, that HIFU can be used as an alternative to surveillance in patients with T1 or T2 tumors and a Gleason score of 6 or less.

“I don’t see it that way. If it’s safe to just monitor people, then I think they should just be monitored,” Dr. Koch said.

Getting payers to cover HIFU for prostate cancer is another challenge since the FDA did not specifically approve it for that indication. Some patients are paying cash for the treatment and then trying to collect from insurers. Dr. Koch said he expects payers will eventually cover HIFU for prostate cancer. The data are strong, he said, that the treatment can be more cost-effective than surgery or radiation.

One drawback to HIFU is that magnetic resonance images and extensive biopsies can yield false-negative results trying to pinpoint the location of the disease. “It’s also too early to determine HIFU’s impact on survival,” Dr. Koch said.

Plenary II Preview
Late-Breaking Session
High Intensity Focused Ultrasound – Hope or Hype?

Moderator: Michael O. Koch, MD
Noon – 1 p.m. Friday
Room 6A, San Diego Convention Center