Targeted HIFU in the treatment of index lesions in localized prostate cancer

A new review article offers us some greater clarity related to the role of targeted, high-intensity focused ultrasound (HIFU) to treat carefully selected areas of the prostate to eliminate primary or index lesions while leaving the remainder of the prostate intact.

In this article, Albisinni et al. provide a pooled analysis of data from 366 patient cases published in seven papers. They report the following:

  • Average (mean) patient age was 67 years.
  • Average (mean) pretreatment PSA level was 6.4 ng/ml (range, 5.5 to 7.4 ng/ml).
  • Gleason scores of patients treated included
    • Up to Gleason 3 + 4 = 7 in three of the seven studies
    • Up to Gleason 4 + 3 = 7 in another three of the seven studies
    • Any Gleason score in one of the seven studies
  • Average (mean) follow-up was just 26 months (range, 23 to 31 months).
  • Early complications rates included
    • Low-grade complications (Clavien-Dindo grades I and II) in 26 percent of patients (range, 16 to 37 percent)
    • High-grade complications (Clavien-Dindo grades III and IV) in 3.8 percent of patients (range, 0 to 8.6 percent)
  • At 1 year post-treatment
    • The negative biopsy rate for clinically significant prostate cancer was 87 percent (range, 79 to 96 percent).
    • The salvage treatment-free survival rate was 92 percent (range, 85 to 92 percent).
    • The reported potency rates ranged from 64 to 84 percent.
    • The reported continence rates ranged from 91 to 100 percent.

It should be noted that definitions of both potency and continence varied across the seven pooled studies.

It is important to appreciate that Albisinni et al. clearly state their opinion that targeted partial ablation of the prostate using HIFU as a treatment for prostate cancer “remains experimental” at this time.

They conclude that:

  • The data from their pooled analysis suggests that partial, targeted use of focal HIFU in treatment of prostate cancer “shows promising oncologic and functional outcomes.”
  • Carefully selected patients “may be candidates for such a conservative partial treatment of the gland”.
  • We still need well-designed trials that can effectively compare partial, targeted use of focal HIFU treatment to current standards of care.

In a separate “Beyond the abstract” commentary on the UroToday web site, Faoud Aoun, MD, offers some additional thoughts on this topic. However, he is again clear that we need more data before this type of therapy can be considered a standard practice in the management of localized prostate cancer.

All this information provides some context to a somewhat hyperbolic media release about a new piece of equipment known as “Focal One”, which has just been approved by the FDA for use in the ablation of prostate tissue. Like every other form of HIFU equipment to date, it is not approved for the treatment of localized prostate cancer. While the Focal One device may well be “the first medical apparatus designed specifically for focal treatment of the prostate” (as claimed in the media release), it is certainly not the only form of HIFU technology that can be used in this way, and the use of such technology has still not been shown to have a high level of efficacy and safety in the treatment of localized prostate cancer with even 5 years of patient follow-up.

2 Responses

  1. I am newly diagnosed and am looking for a HIFU clinical trial where I don’t have to outlay the 24K. I USA federal BlueX/Blue Shield, which does not cover it. I don’t have Medicare. Can anyone help me with specific gratis trials or studies, or even clinics in Mexico or Asia where the treatment cost is reduced?

  2. Dear Daniel:

    If you click here, you will find links to > 20 different trials of HIFU in the treatment of prostate cancer going on around the world. If there is one going on at a center near you, the links will give you more detail and usually a phone number that you can call to discover whether you might be an eligible patient.

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