Morbidity associated with HIFU at three UK academic centers

A group of three centers in the UK has been investigating the appropriate use of high-intensity focused ultrasound (HIFU) since 2004. (We have previously commented on other data reported by this group of investigators led by Drs Emberton and Ahmed.)

In a newly published paper in the Journal of Urology, Berge et al. now report comparative data after initial and repeat use of HIFU in the management of localized prostate cancer. The data are based on validated patient questionnaires that patients were asked to complete after initial HIFU treatment and again after repeat HIFY treatment where this was appropriate. (And the authors are very clear that “Meticulous patient selection is of paramount importance in selecting patients for redo-HIFU.”)

Here is  summary of what Berge et al. report:

  • Their database includes 359 patients with localized prostate cancer treated with first-line, whole-gland HIFU between October 2004 and June 2012.
  • 130/359 patients (36.2 percent) were re-treated with whole-gland HIFU after follow-up suggested incomplete success of initial HIFU therapy.
  • Average (median) follow-up was 27 months (range, 3 to 81 months) after repeat HIFU.
  • Urinary tract infections were observed in
    • 10.8 percent of patients after initial HIFU treatment
    • 3.9 percent of patients after repeat HIFU treatment
  • Dilatation of the urethra was required in
    • 13.8 percent of patients after initial HIFU treatment
    • 14.0 percent of patients after repeat HIFU treatment
  • Bladder neck incision was required in
    • 9.2 percent of patients after initial HIFU treatment
    • 11.6 percent of patients after repeat HIFU treatment
  • Absence of urinary tract leakage was reported by
    • 73.3 percent of patients after initial HIFU treatment
    • 55.1 percent of patients after repeat HIFU treatment
  • Use of daily pads was reported by
    • 2.7 percent of patients after initial HIFU treatment
    • 9.0  percent of patients after repeat HIFU treatment
  • With regard to erectile function/potency
    • 56.2 percent of patients claimed to be potent before and after initial HIFU treatment.
    • 56.0 percent of patients claimed to be potent before and after repeat HIFU treatment.

The authors conclude that repeat HIFU

is associated with an increase in urinary side-effects but sexual side-effects do not appear to be significantly increased. The number of adverse events seems to be equivalent after first and redo HIFU.

There is little doubt that HIFU (as carried out by experienced and well trained specialists) is associated with a lower level of morbidity than radical prostatectomy in comparable patients. On the other hand, > 30 percent of HIFU patients do seem to need re-treatment, even with careful patient selection, and there is still no sign of data from the clinical trials that were intended to support approval of HIFU in the USA.

What we also do not know is how many of the patients from this study would now be considered as good candidates for active surveillance. Dr. Emberton was very clear on a recent teleconference with members of the patient and advocacy community that, in the UK, HIFU is not currently recommended for men who can and should be managed on active surveillance, but some of the early patients treated by this group did seem to meet current criteria for active surveillance.

The “New” Prostate Cancer InfoLink is of the opinion that there is certainly a place for HIFU in the management of localized prostate cancer … but the available data is still weak when it comes to knowing which patients are most appropriate for such treatment (as compared to active surveillance on the low-risk end and as opposed to other forms of invasive therapy for intermediate- and higher-risk patients). In the long term, it may well turn out that the most appropriate use of HIFU is actually as a form of focal therapy in appropriately selected patients who can be managed without whole-gland treatment … but we are going to need more data to confirm this possibility too.

One Response

  1. The following contains no statistics; it’s just my personal experience.

    Diagnosed end of 2007: Gleason 6, PSA 3.8, prostate volume 28 cc.

    I searched the Internet a lot and found out about the HIFU hemiablation option, selected it, and underwent the procedure by Dr. Emberton on January 31, 2008.

    Bottom line: No urine issues; erection a bit slower, however it works very well …. I rarely use Cialis although my urologist recommended a small dose just to get things going. PSA stable @ 1.3 for the past 6 years (small fluctuations). I think that my penis became somewhat smaller.

    Why I opted for hemiablation HIFU: It seemed promising. A saturation biopsy and MRI proved that my cancer was most likely restricted to one lobe, and it was actually on the seminal vesicle. PSA progression prior to the procedure was slow, which means that it was not aggressive, yet being on the seminal vesicle was a red light. I could have selected: watchful waiting, HIFU hemiablation, radical prostatectomy, other. Selected HIFU hemiablation and I am happy with the decision, because:

    (1) I have had no stress about recurrence in the second lobe, and I have been constantly monitoring my PSA level, so it is kind of watchful waiting for one lobe.

    (2) Radical prostatectomy is associated with a high rate of erectile function and urinary function issues; having a young girlfriend, I did not want to take any risk.

    (3) The procedure was really simple and easy; I was bale to start working again the next day (via the Internet) and removed my catheter 5 days thereafter (kept it for a flight back home).

    The Sonablate software and hardware have been modified since my treatment and are much better now.

    I really don’t understand why there are no solid statistics and why, when looking at long-term statistics, the trends are not being considered, as for each method there have been multiple improvements.

    I do not understand why a small sample of 12-14 biopsies is being taken as such biopsies can lead to false negative results. If cancer is detected in only one lobe, why not perform a template-guided saturation biopsy to find out if it is restricted to that one lobe or appears in both lobes, and perform treatment based on this finding (as in my case above).

    Thanks for reading.

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