Early data from a significant UK series of HIFU patients

This initial report contains inaccuracies and is based solely on the abstract of the original paper. A more detailed and accurate assessment of this paper was developed on July 4 after assessment of the complete published paper. Readers are advised to read newer report but you can

Data have just been published on a series of 172 patients with organ-confined prostate cancer treated with transrectal, whole-gland, high-intensity focused ultrasound (HIFU) between February 1, 2005 and May 15, 2007 at two medical centers in the UK.

The men were all treated using the Sonoblate 500 HIFU equipment as opposed to the Ablatherm equipment more commonly available in most of Europe. Outcome data are all based on biochemical responses to treatment, pre- and post-treatment histology using biopsies, and validated patient questionnaires to assess adverse effects of therapy.

The results reported by Ahmed et al. are as follows:

  • 172 men were treated under general anesthesia as day-case procedures.
  • 134/172 patients (78 percent) were discharged at an average of 5 h after treatment.
  • Mean patient follow-up was just under 1 year (range: 135-759 days).
  • The incidence of post-surgical urethral stricture was significantly lower in patients given a suprapubic catheter compared with those given a urethral catheter (19.4 vs 40.4 percent).
  • Antibiotics were given to 23.8 percent of patients for presumed urinary tract infection and the rate of epididymitis was 7.6 percent.
  • Potency was maintained in 70 percent of patients by 12 months.
  • Also at 12 months, mild stress urinary incontinence (no pads) was reported by 12/172 patients (7.0 percent) with once additional patient (0.6 percent) requiring pads.
  • Neither rectal toxicity nor recto-urethral fistulae were observed.
  • 78.3 percent of patients achieved a PSA nadir of  ≤ 0.5 μg/ml at 12 months, and 57.8 percent achieved a PSA nadir of  ≤ 0.2 μg/ml at 12 months.
  • Of the 13 patients who required follow-up treatment because of evident biochemical recurrence, eight were retreated with HIFU, one had salvage external beam radiotherapy, and four chose active surveillance for small-volume low-risk disease.
  • Overall, there was no evidence of disease (PSA <0.5 μg/ml or negative biopsy if nadir not achieved) after one HIFU session in 159/172 patients (92.4 percent).

The authors conclude that “HIFU is a minimally invasive, day-case ablative technique that can achieve good biochemical outcomes in the short term with minimal urinary incontinence and acceptable levels of erectile dysfunction.” However, they then point out, appropriately, that long-term outcome data are needed before we can have evidence of the real clinical value of this technique. The same point is made by several commentators in a BBC news report on this study.

These results continue to show the potential of HIFU in patients with low risk, organ-confined prostate cancer. However, The “New” Prostate Cancer InfoLink would make two points about the data presented in this study:

  • Many of the men treated in this study would seem likely to fall into the category of men who don’t actually need treatment for their prostate cancer at all, but could be adequately managed with active surveillance because their risk of progressive disease over time is minimal. The abstract of the paper does not provide detailed information on the ages, clinical stages, or Gleason scores for these patients prior to treatment, but we assume these are provided in the full text.
  • The risk for post-treatment erectile dysfunction after HIFU in this trial appears to be significant — at about 30 percent after 1 year of follow-up.

What’s the bottom line here? The bottom line is that short-term follow-up of a significant series of patients treated for localized, organ-confined, low-risk prostate cancer with whole-grlad HIFU shows good (but not perfect) outcomes. It is also clear that use of a suprapubic catheter during the prcedure reduced the risk for urethral strictures. But we have a way to go yet before we will know if these data hold up over periods of 5 and 10 years.

2 Responses

  1. In the latest UK trial, the head doctor, Mark Emberton, wrote, “Most of the [occurrences of retained debris or stricture] were clustered to the early part of the series at the beginning of our learning curve” and “If rates similar to those reported in this paper had persisted we would not have wanted to continue with this treatment.”

    Yes, “learning curve”….can you imagine the stellar outcome if the doctors in the trials had actually been experienced?

    Even in America they would not let our most experienced doctors into the clinical trials. They told Dr. Scionti (my HIFU doc) that they were afraid he would have a bias toward the trials being successful, so he wasn’t allowed in.

  2. Ron:

    It’s called a conflict of interests, and it is perfectly normal to exclude from major randomized clinical trials of this type any physician who has a demonstrable business interest in the outcome.

    Also, if you look at the top of this page, you will see a referral to the fact that this is an outdated report and gives a link to a later report that includes the exact quotation from Emberton that you mention.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

%d bloggers like this: