HIFU for Prostate Cancer: New Study Results Disappointing

Hello. I am Dr. Gerald Chodak for Medscape. In November 2010, an article^[1] was published in BJU International looking at the results up to 5 or 6 years after high-intensity focused ultrasound for clinically localized prostate cancer. The study used the second-generation Ablatherm® (EDAP TMS, Lyon, France) device, and it defined biochemical failure as a rise [in prostate-specific antigen (PSA)] of 1.2 ng/mL above the nadir value. This is a newer definition for biochemical disease-free survival.

The investigators followed patients for up to 6 years. Of great concern is that the results show a very high failure rate, either because they needed other therapy or because the PSA increased above this amount. The results showed that the 5-year biochemical disease-free survival rate was only about 20%.

These results are of great concern in terms of an ability to control this disease. It is somewhat surprising to see that many men failing when they had low-risk prostate cancer, since we know that so many of them do well even with active surveillance. This is somewhat difficult to understand.

The other thing that is difficult to understand is why these results are very different from the more recent Sonablate® device (Focus Surgery, Inc., Indianapolis, Indiana) results that are not showing this kind of failure rate.

The bottom line is that [high-intensity focused ultrasonography] is certainly inadequate as a treatment for men with localized prostate cancer. It means that any man who is considering high-intensity focused ultrasound should be made very clearly aware that the failure rate is higher than we expect from other treatments for this disease. In the United States, it is still not an acceptable treatment paid by Medicare to have high-intensity focused ultrasound, with studies in progress.

But there are men who are taken outside the United States to get this therapy, and the question is whether they are being told about these kinds of results when weighing their options. At the present time, it is very difficult to make a case that high-intensity focused ultrasound is a reasonable alternative for managing localized disease with comparable results to surgery or the different forms of radiation. Trying to present anything more formally and encouraging patients to have this treatment would seem to be inappropriate.

From Medscape Urology > Chodak on Urology