HIFU in Prostate Cancer: Are Patients 'Guinea Pigs'?

Gerald Chodak, MD


March 03, 2016

This feature requires the newest version of Flash. You can download it here.

Hello. I'm Dr Gerald Chodak for Medscape. Today I want to talk about high-intensity focused ultrasound (HIFU), which was approved in November 2015 for ablating prostate tissue. By way of history, in 2014, a US Food and Drug Administration (FDA) panel concluded that HIFU was not adequate as a treatment for localized prostate cancer. That conclusion was based on an attempted randomized trial comparing HIFU with ultrasound. That study did not have adequate accrual, and yet, in the men getting treated with HIFU, 28% had a positive biopsy at 2 years.[1]

Fast forward a year, and now the approval states that it can be used for ablating prostate tissue. I'm not exactly sure what that means in terms of using it to treat men with prostate cancer, but the concern here is that it may be mismarketed or misrepresented by clinicians who use HIFU. A question, of course, will be who is going to pay for it and under what pretenses that will occur. The FDA concluded that it was a safe treatment for ablating prostate tissue.

Although the short-term markers are not an indication of long-term effectiveness, by giving it this approval, they have indicated that the companies can accrue more data to look for efficacy. In other words, it means that patients are going to be guinea pigs in an experimental assessment of this treatment without really realizing that they're going to be experimented on for that purpose.

I'm extremely concerned about this approval process because it looks like a backdoor way to get the opportunity to use HIFU in men who have localized prostate cancer. But the real question is, is it good enough? In previous commentaries that I've done, HIFU has not held up well against other treatments for localized disease. In fact, it seems to work best in men who least likely need to be treated.

One has to wonder why the FDA took this approach and whether they are going to caution the company about how it's going to be marketed. Clearly, it cannot be marketed as a treatment for prostate cancer, so under what circumstances would one want to use it in men with prostate cancer who need to get treated for their disease?

We'll have to wait and see how this unfolds and whether Medicare and other payers will decide to pay for it when a man has a diagnosis of prostate cancer. For now, I'm concerned. Hopefully, things will bear out so that patients are protected and not led to believe that HIFU is as good as other therapies for localized prostate cancer in men who really need to be treated. I look forward to your comments. Thank you.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.