Study Oversells HIFU Benefits, Especially in Low-Risk Prostate Cancer

Gerald Chodak, MD


October 23, 2015

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Hello, I'm Dr Gerald Chodak for Medscape. Today I want to talk about a paper by Aoun and coworkers[1] that was published in Advances in Urology comparing low-dose brachytherapy with high-intensity focused ultrasound (HIFU) therapy for men with low- or intermediate-risk prostate cancer.

My reason for discussing the paper is my belief that the study's recommendations and conclusions make HIFU appear better than is warranted by the data.

The researchers did a case/control retrospective analysis, not a prospective randomized trial. They analyzed results comparing patients by case-matching a total of 70 men treated by brachytherapy in a 1:1 ratio with men treated with HIFU. Nearly one half of the men had low-risk disease, and the remainder had intermediate-risk disease. The groups were not completely identical; the men in the HIFU group were a few years older, and the follow-up was longer in the HIFU group.

In the study results, researchers reported a higher biochemical disease-free survival rate for men getting the brachytherapy compared with the men getting the HIFU in the low-risk group, which is statistically significant.

In the intermediate-risk group, there was about a 14% difference in the failure rate that was higher in the HIFU group, but it did not reach statistical significance, possibly because of the sample size and short follow-up.

Another difference between the groups is that nearly one third of the men received androgen deprivation therapy (ADT). The data were not analyzed or stratified to determine whether there were differences in the outcomes according to whether men did or did not receive ADT.

I see the following problems with this study:

  • The side effects of impotence or incontinence appeared to be higher for the HIFU group, at least for the incontinence, but these were not assessed using validated surveys. This makes it difficult to fully analyze this study in terms of overall side effects, as the authors report that they did not use or assess overall quality of life for the different groups.

  • The authors conclude that the results are relatively comparable and that both treatments are safe to treat men with low- or intermediate-risk prostate cancer, but the authors made no attempt to compare their findings with other studies around the world. What is troubling, particularly for someone who is concerned about getting treated for low-risk disease, is that the failure rates were significantly higher than the 10% failure rates seen in men getting treated by surgery, external radiation, or brachytherapy at other centers.

For now, I think one has to conclude that the HIFU results just don't seem as favorable as those for other available treatments. Of course, we have the whole argument about whether to treat low-risk disease in the first place; for men to have a failure rate of over 30% for low-risk disease treated by HIFU, one has to wonder whether it's really a worthwhile treatment for that group of patients.

I look forward to your comments. Thank you.


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