Post-treatment pathology of the prostate after first-line HIFU

One of the unknown factors in the use of high-intensity focused ultrasound (HIFU) for the first-line treatment of prostate cancer is the potential for high-quality, biochemical recurrence-free survival over time. Post-treatment histopathology may offer some insight into the likelihood of good outcomes.

Biermann et al. have recently reported data on the histopathology of tissue from 25 patients who underwent prostate biopsies after first-line treatment with HIFU. All biopsies were carried out at 180 days after initial HIFU therapy.

The results reported by Biermann and her colleagues include the following:

  • 18/25 patients (72 percent) showed tissue necrosis in their biopsy samples (often associated with acute, chronic, or granulomatous inflammation).
  • Mild or moderate fibrosis could be observed in all biopsy cores.
  • 11/25  patients (44 percent) had evident  prostate cancer cells in their biopsy samples after treatment.
    • 9/11 patients (82 percent) showed no apparent effects from treatment.
    • 2/11 patients (18 percent) showed degeneration of the nuclei of prostate cancer cells (“nuclear pyknosis”).

This is a very small study, and we are  given no information (in the abstract) about the pre-treatment status of these 25 patients (i.e., their PSA level, Gleason score, clinical stage, etc.) or the type of HIFU treatment.

Clearly, HIFU had introduced various histopathological changes in prostatic tissues of these 25 patients. However, it is concerning to see the authors’ statement that 44 percent of these patients still had evident prostate cancer cells in their biopsy specimens, and that “there were minimal morphologic changes in residual adenocarcinoma” after HIFU.

The authors, as pathologists, conclude only that their pathology colleagues “should be aware of common histologic findings in prostatic biopsies after HIFU treatment.” They also recommend “routine reporting of Gleason scores in post-HIFU needle biopsies.”

The “New” Prostate Cancer InfoLink continues to believe that more data will be needed to make a compelling case for (or indeed against) HIFU as an appropriate form of first-line therapy for prostate cancer in any but the most carefully selected patients. Clinical trials of HIFU appear to be continuing in the US, but there is a distinct (and somewhat worrisome) lack of information about the numbers of patients who are enrolling in these trials.

9 Responses

  1. I am not surprised by this study. But given the nature of prostate cancer, a slow-acting disease, one has to ask if progression is delayed with this procedure, and is it worth the price? Still, and this is my opinion with a solid understanding of the concept of HIFU, this is clearly a treatment option only for anyone where active surveillance is an option, but the patient doesn’t want to go that route. HIFU has been an overly sold option that lacks clinical data, and is showing less than stellar results in the real clinical studies I have read. One might argue that 56% of these patients were cured, but I also believe that the re-biopsy probably missed the residual cancer in most of those cases. So is it worth paying $25K out of pocket to skirt US law and go out of country to be treated with HIFU ~ Uh … no. There are better options with proven results.

  2. First, I had HIFU and am very happy that I did, I know way too many who had the other treatments who are left with less than quality of life. If cancer returns, I’ll be much happier having another HIFU treatment.

    I am happy to see HIFU discussed, period, as still, doctors do not inform patients this option exists.

    I know someone who was qualified for the HIFU clinical trial that was ongoing at Sloan-Kettering. However, the surgeon at that hospital did not tell him he could have enrolled. This lack of information is one reason the trials haven’t many enrollees. Another reason is the stringent regulations for enrolling.

    No one is “skirting the law” by going outside the country to be treated. They are only giving up insurance (in many cases, not all).

    HIFU is not “overly sold” either, very few people know it exists. And there were no data for other forms of treatment before they were made available.

    The “proven results” with the other treatments is exactly what drove me to HIFU.

    HIFU should be an option right here in the USA. Prostate cancer only attacks adults, who should have the right to weigh all options. Only when doctors push the FDA for approval will it be approved. No other treatment for prostate cancer had to go through the hardship of clinical trials, and in some cases, the cost of the trials puts companies out of business, thereby reducing our “care” in the USA.

  3. “No other treatment for prostate cancer had to go through the hardship of clinical trials, and in some cases, the cost of the trials puts companies out of business, thereby reducing our ‘care’ in the USA.”

    Correct me if I’m wrong, but, I was under the impression that all prostate cancer treatments underwent clinical trials, usually with a placebo arm if they were testing medications.

    You have obviously had first-hand experience with HIFU and are happy with the results, may I ask when you underwent the procedure, and what were your test results, prior and after the treatment and did you have a biopsy after the HIFU?

  4. Gentlemen:

    Just so that we are clear, no amount of “pushing by doctors” will get the FDA to approve HIFU unless there are good data from clinical trials demonstrating a significant clinical benefit from this technique.

    The fact that certain older types of therapy became available without clinical trials is no longer relevant. All completely new procedures are now going to require clinical trials — just as all new drugs have done for years.

    And it is certainly not true that, “No other treatment for prostate cancer had to go through the hardship of clinical trials.” Every new prostate cancer drug has been through clinical trials since the mid 1960s.

    Other forms of therapy may have been approved without clinical trials if they were “substantially equivalent” to legally marketed devices used for comparable clinical purposes — but this form of approval is likely to become a great deal less common in the near future because it has led to approvals of products and equipment of demonstrably dubious clinical value.

  5. True, other treatments for prostate cancer did not go through the trials, but were approved because of another treatment. No other treatment has gone through trials for prostate cancer. HIFU is also used for kidney stones, myoma embolization‚ hysterectomy‚ and uterine fibrosis.

    HIFU was invented in 1941 in Indianapolis, Indiana, as a treatment for prostate cancer.

    HIFU has been shown to not cause damage, except in rare cases and for this reason we will always question what is behind keeping a pain free no side effect cure from the public, when what is pushed and marketed has proven to be so detrimental.

    There’s a device that cures blindness that will never get to market because of the cost of clinical trials (60 Minutes report), our FDA is over-reaching and causing us to question their ethics.

    John, I was treated by Dr. Scionti back in Dec. of 2008, my PSA was 8.2 prior and now it’s 0.5, which is excellent for post HIFU as I still have a gland. As long as it stays low and stable there’s no reason for a biopsy.

  6. After HIFU my cancer came back within a year. What other treatment can I have?

  7. Dear Les:

    Almost any other widely used form of treatment can be applied after initial HIFU, including surgery and various forms of radiation therapy — if your cancer is still localized to your prostate. The appropriateness of each technique would depend, at least to some extent, on your age, other health factors, your original prostate cancer diagnosis (inlcuding your PSA level and your Gleason score), where your doctors think your cancer may be recurring, etc.

    The first thing you need to get an opinion on is whether you do, indeed, still have localized prostate cancer, or whether the cancer has already spread outside of your prostate. Even if the cancer has started to spread into the pelvic area, highly effective forms of treatment can still be administered using combination therapies such as radiation and hormonal therapy.

  8. Is there info on life after recurring cancer and robotic surgery or HIFU after the second time?

  9. Dear Les:

    Can you clarify your question for me? Are you asking about the possible roles of robot-assisted surgery or HIFU after two prior forms of treatment?

    The possibility for use of such therapies on a man with a rising PSA after two earlier forms of therapy would depend — at a minimum — on exactly what those therapies had been and on the man’s original risk factors (PSA, clinical stage, Gleason score, etc., at time of diagnosis).

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