Apical prostate cancer and recurrence after HIFU

The presence of prostate cancer in the apex (the lowest tip) of the prostate is always a challenging aspect for treatment of localized prostate cancer, because this places the cancer close to the nerves that control erectile function (potency) and to the sphincter (valve) that controls urine flow.

Boutier et al. wanted to know whether the location of cancer within the prostate affected outcomes after high-intensity focused ultrasound (HIFU) in the treatment of men with localized prostate cancer in their series of French patients (all treated with the Ablatherm HIFU technology). To do this they carried out a retrospective analysis of data from 99 patients, all of whom were treated with first-line HIFU for localized disease, and also received systematic biopsies 3 to 6 months post-HIFU as part of the routine post-treatment follow-up.

The following points are worth noting:

  • All patients received sextant biopsies before and after treatment.
  • All patients were given HFU with a standard 6-mm safety margin at the apex of the prostate in order to “spare” the urinary sphincter and the extrasprostatic nerve bundles.
  • All patients with sextant biopsy cores that were negative before treatment and and positive after treatment were recoded as positive/positive, on the premise that cancer had been missed at the pretreatment biopsy, and all patients with such sextant biopsy data were excluded from the study results.

Here are the results of their analysis:

  • Pre-HIFU biopsies found cancer in all 99 patients.
  • Pre-HIFU biopsies found cancer in 215/594 sextant biopsy cores (36.2 percent).
    • 55/215 positive sextant biopsy cores (25.6 percent) were in the apex of the prostate.
    • 86/215 positive sextant biopsy cores (40.0 percent) were in the mid-gland of the prostate.
    • 74/215 positive sextant biopsy cores (34.4 percent) were in the base of the prostate (the area closest to the bladder).
  • Post-HIFU biopsies found residual cancer in 36/99 patients (36.4 percent).
  • Post-HIFU biopsies found cancer in and 50/594 sextant biopsy cores (8.4 percent).
    • 30/50 positive sextant biopsy cores (60.0 percent) were in the apex of the prostate.
    • 12/50 positive sextant biopsy cores (24.0 percent) were in the mid-gland of the prostate.
    • 8/50 positive sextant biopsy cores (16.0 percent) werein the base of the prostate.
  • Two different sets of statistical analysis found that the locations of the positive sextants before and after HIFU were significantly different (P < 0.001).

Boutier et al. conclude that when a 6-mm apical safety margin is used at the apex of the prostate in the treatment of men with Ablatherm-based HIFU, residual cancer is found significantly more frequently in the apex than in the mid-gland or the base of the prostate. They further note that new strategies to improve the elimination of prostate cancer tissue at the apex of the prostate (by HIFU) while preserving urinary continence (and presumably potency) will need to be found.

Whether the same problem affects the probability of prostate cancer recurrence after treatment of men with HIFU using Sonablate-based technology is not known at the current time. If the same 6-mm safety margin is used when applying HIFU using Sonablate technology, then there would seem to be a significant likelihood that similar results would be evident if a similar study was carried out.

It is also worth noting that Boutier et al. state that the 5-year progression-free survival rates after HIFU for localized prostate cancer using Ablatherm technology are between 66 and 78 percent.

7 Responses

  1. Getting another 2-hour pain free outpatient HIFU treatment would be far superior to initial surgery plus radiation, or seeds failing or radiation failing with all the side effects and the mental anguish one has to deal with with the conventional treatments … if only HIFU was available here.

    The doctor who invented HIFU had prostate cancer surgery when he invented HIFU back in 1941 … He said “No man should have to go through what I have had to deal with.” Here we are 70 years later … catering to the medical $$ industry instead of catering to the patient.

    Bottom line on the article above, HIFU works, with cancer in the apex one needs a skilled doctor running the machine so that he can get all the cancer, and if he doesn’t on the first try, a second round is far easier on the patient than the treatments they push.

  2. And as we have said many times before, the onus is on the manufacturers of HIFU equipment to encourage enrollment of patients into clinical trials to prove the efficacy and safety of HIFU … as with any other new form of treatment. Ron is entitled to his personal opinions … but the FDA needs more than personal opinion to support the approval of HIFU in the USA. Since there are now no ongoing trials of the Sonablate technology as a first-line treatment for prostate cancer (that we are aware of), it is highly unlikely to be approved for this use in the USA within the next 10 years.

  3. Clinical trials are wonderful for those companies with deep pockets, many small companies are bankrupt and their treatments are lost trying to get approvals. Both HIFU companies were in clinical trials, but chose to quit, one has to wonder why ~ did the FDA make the rules so stiff no one could fulfill the agenda? However there is one clinical trial ongoing ~ the one where they use Sonablate HIFU after radiation fails. Our system caters to the large drug companies. A treatment such as HIFU with such a small amount of negatives, no mortality, and retreatment which is painless and quick (no drugs …) should have doctors pushing to get it approved, but alas those same doctors are too busy stuffing their pockets. Those doctors also leave the country to get HIFU for their own prostate cancer
    Seems that I heard that radiation was approved for prostate cancer based on the trials of another treatment with radiation. HIFU is approved for uterine fiberoids…..if it was a fair world HIFU would be approved on that trial.

    We live in an ugly world when people who own this site and have the ability to speak up and make a difference in health care ~ won’t.

  4. Dear Ron:

    As a primary “owner” of this site, I speak up all the time. You just don’t happen to agree what I have to say, which is very simple …

    If the manufacturers of Sonablate and Ablatherm equipment want to get HIFU approved for the treatment of prostate cancer in the USA, they need to do a better job of working with the FDA and the specialty prostate cancer community. They — and you — may not like it, but it’s a fact of life. In the meantime, as you well know, I regularly advise patients with low-risk disease (who may not need treatment at all) that HIFU is available and may be appropriate for them if they are willing to work with experienced physicians who offer HIFU in Mexico and the Caribbean. I also encourage them to participate in any trials that are available.

    You also appear not to be aware that products like the Ablatherm and Sonablate technology are reviewed within a division of the FDA that has nothing to do with drugs at all but is entirely focused on the review of applications to market medical devices.

    Radiation therapy has never been “approved” for the treatment of prostate cancer. The use of radiation therapy to treat cancer was “grandfathered” because it has been used regularly to treat cancer generally (and prostate cancer specifically) since about the early 1930s. New technology to deliver radiation therapy (e.g., CyberKnife radiation) has been approved through the 410(k) process because it is just a slightly different way to do something that is already accepted practice. The reason the FDA wants good trials of HIFU for the treatment of prostate cancer is that HIFU has never been shown in a randomized clinical trial to effectively and safely treat any type of cancer. The ability to shink uterine fibroids (a subject that I know a good deal about) is by no mean the same as having a demonstrable biocidal effect on cancer cells in the prostate.

    I would note in passing that the developers of the Sonablate and Ablatherm technology might have been a good deal more successful if they had tried working more closely with some members of the radiation oncology community in developing clinical trials of HIFU for prostate cancer. Radiation oncologists are much more familiar with the use of technological methods for the treatment of prostate cancer, and HIFU might have provided radiation oncologists with an opportunity to become the first-line treaters of many more men with early stage, low-risk prostate cancer.

  5. My dad had HIFU treatment almost 3 years ago. His PSA was basically zero after until the past 3 months when it has been rising. It is now 0.18 but it started from about 0.03. What is considered as a start of recurrence for HIFU patients? I read that for prostatectomy a PSA of 0.2 and rising is a sign for recurrence.

  6. Dear Angelica:

    It would appear that you father may well have biochemical recurrence. The important question is going to be what his PSA doubling time is, which you should be able to estimate in another couple of months.

  7. Thanks for your reply. How does the doubling time work? Like for now his PSA already rose 6 times from where it started.

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