Should HIFU Be Presented as 'Experimental'?

Gerald Chodak, MD


May 15, 2012

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Hello. I am Dr. Gerald Chodak for Medscape. A recent article was published about a study of high-intensity focused ultrasound (HIFU), conducted in Europe. Pinthus and colleagues[1] prospectively evaluated more than 450 men who were treated between 2005 and 2010. They have a 2-year median follow-up and they are reporting 4-year biochemical disease-free survival using several different definitions. Their results look promising, but one would have to be very critical about their conclusions, because their range of results for low- and intermediate-risk disease look inferior to those of treatments such as radical prostatectomy and external radiation. At this time, it is too early to say how HIFU will compare to these other treatments when we have long-term follow-up. To report these results is interesting, but it doesn't reveal enough about the adequacy of the therapy. We need longer-term survival. Prostate-specific antigen is not an adequate predictor of the results. So for now, this is interesting. Pinthus and colleagues are to be applauded for accumulating those patients and following them prospectively, but we need much longer follow-up to be able to tell how this study compares with men treated in other ways.

The other thing that is lacking in this study, and may be forthcoming in other studies, are data on complication rates. What is the morbidity associated with this treatment? At least from some other studies, the issues that have been raised are of some concern. For now we have a sizable study with very minimal follow-up that suggests that biochemical disease-free survival might be good enough, but I don't believe it is comparable to other treatments.

The issue really comes down to, what are we going to tell patients going forward? If a man is actually considering HIFU, does this study demonstrate that this is a satisfactory, adequate, or equivalent therapy? The answer in my mind is no, it does not. There is a concern about the biochemical disease-free failure rates that they are reporting, and without longer follow-up, we can't tell patients what to expect. Patients who receive this treatment should be part of an institutional review board -approved protocol so that they are aware that the long-term results are not known, an experiment is going on, and they are being asked to participate. Hopefully that will at least protect the patients who are engaging in this new therapy. I look forward to your comments. Thank you.


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