Salvage HIFU in men with a rising PSA after first-line surgery

We have long presumed that it would be possible to consider high-intensity focused ultrasound (HIFU) as a form of salvage therapy for men with biochemically recurrent disease after either surgery or radiation therapy. Now there are some data on this concept.

In a paper in Minerva Medicine, an Italian clinical research group (Palermo et al.), based on Rome, have reported early data on a small cohort of patients who had local recurrence of their prostate cancer after first-line surgery.

Since (as yet) there is no established definition of short- or long-term biochemical recurrence-free survival in this type of patient after HIFU, the authors chose to define this as a PSA level of ≤ 0.4 at 3 months after HIFU (which seems like a reasonable number). Here are the basic study data:

  • 22 men with local recurrence of their prostate cancer after radical prostatectomy were given HIFU as first-line salvage therapy.
  • Average (median) follow-up was 48 months.
  • 10/22 patients had a nadir PSA of ≤ 0.4 ng/ml at 3 months post-HIFU.
  • 12/22 patients were classified as failures during follow-up.
  • 17/22 patients were continent (no pad use) prior HIFU.
  • 5/17 previously continent patients had a new diagnosis of early onset stress urinary incontinence post-HIFU.
  • One case of vesico-ureteral anastomotic stenosis needed treatment.
  • There were no evident cases of recto-urinary fistula or persistent lower urinary tract symptoms.
  • 2 patients reported de novo erectile dysfunction post-HIFU.

Whether these results are promising or not may depend to a large extent on individual points of view. The authors clearly did feel they were promising, stating in their conclusion that these data

represent the basis to start more organic, prospective, randomized and multicenter study protocols, that with a long term follow-up could confirm these promising preliminary results.

Others may feel that a success rate of about 54 percent may not be as good as one would like to see, although the complication rate does appear to be relatively low. A key question is obviously going to be how well one could pick the right patients for this type of salvage therapy.

3 Responses

  1. I’m a bit confused as to how this works:

    (1) I presume that the site of recurrence is unknown, so where exactly do they focus the high-intensity ultrasound?
    (2) If salvage HIFU fails, is radiation an option for second-line salvage therapy?

    Also, I’d like to know what the pre-salvage PSA of these patients was. Given recent reports (e.g., see here) of big benefits for much earlier initiation of salvage radiation therapy, their definition of “success” as PSA < 0.4 at 3 months after HIFU seems to me a rather generous definition of "success".

  2. Dear Tom:

    With regard to your first question, I don’t think we can make any assumptions about the site of recurrence without a careful review of the entire paper (as opposed to just the abstract). If the recurrence was in the prostate bed, and they knew this for a percentage of the patients, then clearly that’s where one aims the HIFU. As I stated in the very last sentence of this commentary, “A key question is obviously going to be how well one could pick the right patients for this type of salvage therapy.” This is clearly no more than a pilot study of what I would consider to be at best an investigational technique, and I don’t think we should be “over-analyzing” it.

    With regard to the second question, the answer is almost certainly “Yes”, radiation therapy would still be an additional option (but then so might a repeat HIFU).

    The potential advantage of salvage HIFU over salvage radiation therapy is that if it can produce similar oncologic outcomes, it is also likely that it can do so with less risk for serious side effects than salvage radiation therapy … but first we have to find out whether it is able to provide similar oncologic outcomes. In theory I see no reason why salvage HIFU shouldn’t be usable just as early as salvage radiation therapy, and this might also improve the outcomes of salvage HIFU.

    With regard to the patients’ pre-salvage PSA levels, my bet is that, again, these are given in the full text of the paper, but I haven’t seen that full text. However, if the authors were defining success as a stable PSA level of < 0.4 ng/ml, then one has to assume that all the patients had a PSA of about 0.5 ng/ml or higher at the time of salvage HIFU.

  3. You can find more papers on salvage HIFU for prostate cancer at this link.

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