Korean study says that HIFU “does not provide effective oncologic outcomes”


A new paper by clinical researchers in Korea has concluded that treatment with high-intensity focused ultrasound (HIFU) “does not provide effective oncologic outcomes even in low risk patients with prostate cancer as well as in the intermediate or high risk groups,” but does have a low associated incidence of treatment complications.

The value of HIFU as a first-line treatment for localized prostate cancer has become a highly controversial subject, with some strong advocates and some seriously concerned detractors. The “New” Prostate Cancer InfoLink has tried hard, over the past 4 years, to emphasize the importance of good long-term data in making decisions about the potential of HIFU as a treatment for localized prostate cancer.

The recent paper by Sung et al. reports data from a series of about 126 patients with localized prostate cancer given first-line treatment with HIFU between February 2004 and August 2010 and followed for up to 7 years. We have only seen the abstract of this paper.

The patient data were all reviewed for information on oncologic outcomes and complications. Biochemical recurrence was defined as having occurred in men with a PSA value 1.2 ng/ml higher than the PSA nadir (the so-called Stuttgart criteria), and Kaplan-Meier analyses were carried out to evaluate biochemical recurrence-free and clinical progression-free survival according to risk stratification.

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

  • The overall rate of biochemical recurrence was 59.5 percent.
  • The median time to biochemical recurrence was 13.8 months.
  • The rates of 5-year, biochemical recurrence-free survival were
    • 66.3 percent among patients with low-risk disease
    • 40.2 percent among patients with intermediate-risk disease
    • 21.0 percent among patients with high-risk disease
  • The rates of 5-year clinical progression-free survival were
    • 73.5 percent among patients with low-risk disease
    • 46.0 percent among patients with intermediate-risk disease
    • 29.2 percent among patients with high-risk disease
  • Risk stratification, PSA nadir, and time to PSA nadir were significant predictors of biochemical recurrence and clinical progression.
  • In the first 3 months post-surgery, 11 patients (8.7 percent) had complications.
  • No patients required blood transfusions.
  • No patients had wound problems, stroke, deep vein thrombosis, or bowel dysfunction.

As indicated above, the authors state clearly their opinion about the lack of effective oncologic outcomes of HIFU and go on to state that, “patients selected to undergo HIFU treatment for prostate cancer must be very carefully chosen. On the other hand, HIFU treatment for prostate cancer had a very low rate of complications.”

The precise type of HIFU equipment used in the treatment of these patients is not stated in the abstract.

7 Responses

  1. We now have a number of HIFU studies reporting biochemical (PSA based) recurrence free survival at five years. My recollection is that they all indicate that HIFU is not an effective first-line treatment, even in men diagnosed with low-risk prostate cancer. The success rates reported for low-risk men seem similar to what we would have expected if those men had taken an active surveillance approach, suggesting that HIFU is adding little or nothing to success.

    How do the strong advocates of HIFU explain these discouraging findings? (I’m aware that some centers for HIFU and advocates report results that look good at the 1- and 2-year time points but do not report available results from the same series that turn discouraging at the 5-year point and later.)

  2. Jim:

    I would characterize this a rather different way.

    It seems to me that there are significant numbers of men who do appear to get good outcomes from HIFU at 5 years, with low to minimal rates of complications. There are also men who get not-so-good or poor results from HIFU because either they get good oncologic results with significant side effects or they get poor oncologic results (with or without significant side effects).

    The problem is that we don’t seem to able to know up front who will and who will not do well in order to apply HIFU primarily to those who will benefit the most and with the least risk of complications. This is nothing new in the world of prostate cancer. We see the same problem with almost every form of active primary therapy. And on top of this is the issue of whether the people who do do well on HIFU are, in fact, the men who would have done as well or nearly as well on active surveillance, which is a separate question.

  3. As of October, 2012, I am 6 months out of HIFU done by Dr. Stephen Scionti in Bermuda and my PSA is down to zilch. I have no side effects such as impotence or incontinence, something that is grossly under-reported by RALP patients and under-explained by RALP urologists.

    Although I agree that a larger group of post-HIFU men should be studied, I cannot over-emphasize the importance of choosing the most accomplished and experienced urologist to do HIFU should that be your choice. In my opinion, huge strides have been made in HIFU using advanced proximity mapping of the prostate, identifying the nerve bundles, and desired temperature ranges to assure success and minimizing the side effects that compromise post RALP patients.

  4. I had a normal PSA of 1.0 ng/ml on February 28, 2014 while on finasteride and a normal free PSA of 0.22. … My digital prostate exam showed a concretion of rectal mucosa overlying the prostate and it was difficult for the examiner to demonstrate mobility. Otherwise, the prostate digital exam done by a board certified urologist has always been normal. The volume of my prostate was 34 ml and normal. I had no symptoms except for a huge family history of prostate cancer on my mother’s side of the family: very aggressive prostate cancer with early, bone metastasis that killed three uncles and my maternal grandfather. My surviving uncle had a radical surgical removal of the prostate, as did my brother (1 year younger than myself).

    I’ve decided on the HIFU prostate treatment offered in Toronto, Canada by Dr Orovan using the Ablatherm machine since I understand it’s both more accurate and safer than the Sonablate 500. There are far fewer research studies done using Sonablat 500. I have two younger brothers who have no signs or symptoms of prostate cancer (normal digital exams, normal PSAs and free PSAs). Would anyone like to bet on the biopsy results? LOL?

    Ron

  5. Need to mention the biopsy report. … It showed a slow-growing adenocarcinoma in 2/12 biopsy cores taken. One of the two had 64% adenocarcinoma in the right mid lateral and the other had 13% adenocarcinoma in the right base lateral. Both carried a 3 + 3 = 6 Gleason score. In the left apex there was a small focus of atypical glands, highly suspicious for prostatic adenocarcinoma. Will consider another biopsy since I’m very concerned about missing a much more lethal type of aggressive prostate cancer.

  6. Dear Dr. Rosen:

    Not that I have any personal experience, but I think there would be a lot of people who would not agree with whoever told you that the Ablatherm technology is “both more accurate and safer than the Sonablate 500.” I would, on the other hand, agree that there are far fewer published data about the effectiveness and safety of HIFU using the Sonablate system.

  7. I do wish Dr. Rosen success using Dr. Orovan for his HIFU. But to suggest that Ablatherm is “more accurate and safer” than Sonablate 500 is truly not true. Both computerized medical devices are effective in the hands of the most competent/experienced physicians operating it. And that is true for every treatment choice.

    Ablatherm has a longer history since most HIFU physicians in Europe use that device and have for a longer period of time. If you are still having questions about your situation, I would strongly suggest 3-T MRI so you know exactly the location and extent of the risk for the ablation.

    And I would ask Dr. Orovan for his personal data on HIFU: number of procedures done, types of patients, side effects, and subsequent salvage treatment frequency.

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