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A new review of recent clinical outcomes after HIFU

Posted Oct 19 2010 12:00am

High-intensity focused ultrasound (HIFU) continues to gain advocates as a minimally invasive form of treatment for patients with localized and locally advanced prostate cancer, as well as for patients requiring salvage therapy after first-line radiation and after radical prostatectomy.

Data supporting the use of HIFU for treatment of prostate cancer are still limited, but Warmuth et al. have just published a systematic review of reported data on the use of HIFU for first-line therapy and for salvage therapy in radiation failures.

The authors include in their review data from 20 uncontrolled, prospective case series published in either English or German. They included only case series with 50 or more patients. The quality of the data reported was assessed using the so-called Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

According to the abstract of their paper:

  • The case series included a minimum of 58 and a maximum of 517 patients treated with HIFU.
  • All patients were treated during the past 10 years (i.e., between 2000 and 2010).
  • The total number of patients treated was 3,018.
  • For all HIFU procedures
  • Rates of adverse events included

The authors also state that, “Quality-of-life assessment yielded controversial results.” They conclude that, ” the available evidence on efficacy and safety of HIFU in prostate cancer is of very low quality, mainly due to study designs that lack control groups.”

The “New” Prostate Caner InfoLink continues to hold the opinion that, over time, HIFU will come to be seen as a reasonable treatment option for carefully selected patients. It’s value as a curative therapy for men who actually need curative treatment (as opposed to active surveillance) is still to be determined. However, it is also clear that experienced clinicians are able to obtain good clinical outcomes with low (but not negligible) levels of side effects in carefully selected patients.

At this time, it is certainly arguable that HIFU is a option for first-line treatment for men with low-risk prostate cancer who are unwilling to consider active surveillance. However, we need better data before HIFU is endorsed as a safe and effective therapy for men with more advanced forms of localized disease or for salvage therapy in men who have failed other forms of first-line treatment.

At this time, HIFU is available in several European countries and at a variety of other locations with low levels of regulatory oversight. It has not been approved as a treatment for prostate cancer in the USA, where clinical trials are ongoing. The relative clinical merits of the two major commercial forms of HIFU treatment (the Sonablate equipment and the Ablatherm equipment, both in their most recent technical evolutions) are also not well defined.

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