Ablatherm HIFU data on 5,000+ patients with T1 to T3 localized prostate cancer


Another paper to be presented at the upcoming annual meeting of the American Urological Association (AUA) offers us some additional data on the effectiveness and safety of high-intensity focused ultrasound (HIFU) carried out using the Ablatherm technology and recorded in the @-Registry database.

Eduard et al. write in their abstract that, “In [recent] years, HIFU has been recognized as a therapeutic option in patients over 70 years old with 10 years’ life expectancy” (see abstract no. 1205 in the online abstracts for the AUA meeting). We have not seen any specific evidence of this, but the authors use it as a rationale to justify analyzing data from the @-Registry database in two subsets — for men < 70 years of age and for men > 70 years of age.

Here are the data provided in the AUA abstract:

  • The analysis is based on data from 5,206 consecutive patients enrolled in the database.
    • All patients were treated with Ablatherm HIFU technology at one of 16 European centers.
    • Patients all had clinical stage T1, T2, or T3 prostate cancer
    • 2,291/5,206 patients (44.0 percent) were < 70 years of age.
    • 2,915/5,206 patients (56.0 percent) were > 70 years of age.
    • Patients were also stratified according to their D’Amico risk group.
  • Average (median) patient follow-up was 3.4 ± 2.9 years.
  • The patients’ average (median) PSA nadir was 0.15 ng/ml and this nadir was reached at a median time of 14.0 ± 11.5 weeks post-treatment.
  • Negative biopsies post-treatment were obtained from
    • 70 percent of men < 70 years of age
    • 73 percent of men > 70 years of age
  • Estimated actuarial rates of biochemical disease-free survival (bDFS) at 5 years were
    • 84 percent among men with low-risk disease who were < 70 years of age
    • 73 percent among men with low-risk disease who were > 70 years of age
    • 74 percent among men with intermediate-risk disease who were < 70 years of age
    • 65 percent among men with intermediate-risk disease who were > 70 years of age
    • 69 percent among men with high-risk disease who were < 70 years of age
    • 63 percent among men with high-risk disease who were > 70 years of age
  • Side effects reported in the abstract include
    • Urinary incontinence (grades II and III) among 4 percent of men who were < 70 years of age
    • Urinary incontinence (grades II and III) among 7 percent of men who were > 70 years of age
    • Bladder outlet obstruction and/or urethral stenosis among 18 percent of men who were < 70 years of age
    • Bladder outlet obstruction and/or urethral stenosis among 19 percent of men who were > 70 years of age

The authors conclude that, “HIFU presents positive oncological and functional outcome in patients both below and above 70 years. HIFU treatment appears therefore as a valuable therapeutic option for prostate cancer control independent of age.”

What the “New” Prostate Cancer InfoLink finds interesting in this abstract is that the rates of bDFS are consistently somewhat lower in the older men than in the younger ones and that the reported side effects are consistently more common in the older men than in the younger ones. These differences may well be small, and they may well not be statistically significant (the authors offer us no guidance on this matter in their abstract); however, they do seem to contradict the idea that HIFU is a particularly good therapeutic option for older men with localized prostate cancer as opposed to younger ones.

The other point to be noted is that an unknown number of these 5,206 patients may well have been good candidates for active monitoring of some type as opposed to any form of immediate intervention.

One Response

  1. DISAPPOINTING, UNCOMPETITIVE SUCCESS LEVEL FOR HIFU FOR MEN WITH LOW-RISK PROSTATE CANCER (AND DISAPPOINTING FOR OTHER RISK LEVELS TOO)

    Unlike the recent British study, where it appears there was decent success for low-risk patients, the 5-year projected bDFS rates for low-risk men both younger (84%) and older (73%) than 70 appear substantially below the success rates achieved in many series for surgery and radiation (with modern dosing). This disappointing level of success with HIFU is consistent with the other HIFU studies with which I’m familiar, with the sole possible exception of the recent British series (depending on what the success for low-risk men turns out to be after being teased out from the overall result).

    Shouldn’t we expect an effective therapy in 2013 to be achieving about 90% to nearly 100% success for low-risk men? That’s what I’m seeing reported in many studies. (That success range is based on the relatively low levels of active surveillance at the times of those studies. Obviously, with greater use of active surveillance in the future, the pool of patients in future studies with “low-risk” disease is actually likely to have somewhat higher risk disease even if still classed as low-risk as active surveillance will have taken away some of the “low hanging fruit” opportunities for a “cure” that really was not necessary. That historical development, should it occur, will tend to cause decreased rates of success even if the effectiveness of therapies remains the same. However, we are now in 2013 comparing apples with apples success wise, and HIFU results just do not look good!)

    Unless the British study pans out with good results for low-risk men, and hopefully with an explanation how superior results were achieved, I don’t see how we survivors can recommend HIFU be considered by our newly diagnosed buddies reasonable option.

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