New data suggest that salvage HIFU after EBRT is “a high-risk procedure”

A new article reports data from two centers on experience with whole-gland high-intensity focused ultrasound (HIFU) salvage therapy for local recurrence following external beam radiation therapy (EBRT).

The study by Ahmed et al. is a retrospective review of data from 84 men treated by a total of six experienced HIFU specialists between 2004 and 2009 in two consecutive series at one or other of two centers (one in Canada and the other in the UK).

All patients exhibited biochemical failure after EBRT. They were all proven to have local recurrence (by biopsy) and received bone and pelvic MRI scans to exclude the occurrence of evident metastases. All patients received HIFU using the Sonablate 500 system. The Phoenix criteria (PSA >nadir+2 ng/ml) were used to assess biochemical progression. Salvage HIFU was also considered to have failed if they demonstrated a positive biopsy post-HIFU or required hormone therapy post-HIFU.

The results of this retrospective analysis showed that:

  • Average (median) age of the patients was 68 years (range, 64 to 72 years).
  • Average (median) serum PSA level before treatment was 4.3 ng/mLl(range, 1.9 to 7.9 ng/ml).
  • Average (median) pre-treatment biopsy Gleason score  was 7 (range, 6-7).
  • Average (mean) follow-up was 19.8 months (range, 3.0 to 35.1 months).
  • After salvage HIFU,
    • 62 percent of the men were pad-free and leak-free.
    • Average (mean) International Index of Erectile Function-5 point score fell from 8.8 to 4.7 (P < 0.001).
    • International Prostate Symptoms Score and RAND-SF36 scores were not affected.
  • Two men developed rectourethral fistulae after one salvage procedure.
  • 2/6 men also developed rectourethral fistulae after a second salvage HIFU.
  • Intervention for bladder outlet obstruction was needed in 17/84 patients (20 percent).
  • For all 84 patients, inclusive of PSA non-responders,
    • 1-year progression-free survival was observed in 50/84 patients (59 percent).
    • 2-year progression-free survival was observed in 36/84 patients (43 percent).
  • If 7 patients who were PSA non-responders are excluded,
    • 1-year progression-free survival was observed in 48/77 patients (62 percent).
    • 2-year progression-free survival was observed in 37/77 patients (48 percent).

The authors conclude that:

Salvage whole-gland HIFU is a high-risk procedure. Although its use in early cancer control is promising, strategies to better identify metastatic disease prior to salvage therapy and reduce local toxicity are needed to improve on this.

It is only appropriate to note that these data (from two respected groups who have specialized in the application of HIFU and consistently provided full data on the results from their studies) appear to be rather less positive about the outcomes of patients after salvage HIFU than some of the earlier reports to date.

4 Responses

  1. Are there similar data for salvage HIFU after first HIFU treatment?

  2. Chuck:

    No … Proton therapy and HIFU are very different animals. Proton beam radiation therapy (PBRT) is just one of many different forms of external beam radiation therapy. HIFU is based on beams of focused ultrasound. In theory it would be possible to use HIFU in men who had biochemical progression after PBRT.

  3. Wolfram:

    The use of second-line HIFU after first-line HIFU is already commonplace in men who don’t have a full response to a first round of HIFU. The quality of outcomes of men who need second-line HIFU after first-line HIFU is not yet particularly well documented, however.

  4. Wolfram:

    There are “some” data … but they are not well supported by information on the side effects and complications of repeated HIFUs. Drs Ahmed, Emberton, and their colleagues are one of the very few groups who have specialized in HIFU that have consistently reported and published detailed outcome information from their series of patients.

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