Patient choice and the effectiveness and safety of HIFU


An interesting article has just been published in the Journal of Urology which helps to provide information (and context) about the quality of data supporting the use of high-intensity focused ultrasound (HIFU) in the treatment of prostate cancer. This article by Babalola et al. comes from staff at the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA).

Although HIFU was approved relatively recently for “prostate tissue ablation”, it has never been approved in the US for the treatment of prostate cancer.

The authors report their findings from a detailed literature search (inclusive of all reports submitted to the FDA) that addressed:

  • The effectiveness and safety of HIFU
    • When used in the first-line treatment of localized prostate cancer
    • When used as a form of second-line, salvage therapy in the management of localized prostate cancer
    • When used either within the US or elsewhere
  • Patient preference information (PPI) on HIFU-related safety and effectiveness outcomes

Their findings were as follows:

  • There are “no HIFU effectiveness data relevant to clinical decision-making such as overall survival or prostate-cancer-specific survival in the US.”
  • “Long-term effectiveness data from outside the US are sparse and outcomes are variable.”
  • There are “no patient preference data on HIFU treatment in men with prostate cancer.”

Your sitemaster would generally agree with these findings (although he is aware he may not have seen all of the data presented to the FDA because some of those data may be confidential).

Babalola et al. conclude that

The lack of long term HIFU oncological data in a United States population has brought new challenges to prostate cancer stakeholders including clinicians, patients, and the FDA. PPI from future patient studies on HIFU could provide additional information to patients, clinicians, and current and prospective device developers.

They further note that if such data existed it could “be used by regulators in their risk-benefit evaluation for this class of treatment devices.”

The message to the developers and marketers of HIFU technology — and to the patients who are interested in seeing such technology approved for the treatment of prostate cancer — is a clear one: “Bring us sound data and we will consider it.” Such data could specifically include data on patients’ willingness to opt for treatment with HIFU over other management options (i.e., PPI), which might include active surveillance, radical prostatectomy, radiation therapy, and other forms of management if the information provided to patients had been presented in a well-structured, well-documented, and neutral manner.

In other words, the FDA appears to be willing to consider approval of HIFU for the treatment of localized prostate cancer if it can be demonstrated that sufficient numbers of patients would select such a treatment option over other accepted forms of management when it is presented as one of several possible management options with the relevant supporting data.

This is actually — in the opinion of your sitemaster — a very interesting development. The “New” Prostate Cancer InfoLink has long advised selected, individual patients that HIFU might be an appropriate management option for them, while simultaneously cautioning that the long-term data on effectiveness and safety of this form of treatment has been less than entirely compelling. We believe in the right of patients to make the best decision about management and treatment for prostate cancer that “works” for them as individuals. If it can be shown that a sufficient percentage of newly diagnosed patients would choose HIFU as their first-line management option over other forms of therapy based on the currently available data, then patients should have the right to be treated that way — so long as they also appreciate that (a) it doesn’t always work and (b) it can have some significant side effects.

And, as always, in addressing this issue, we would point out that it takes skill, training, and experience to learn to use HIFU really well. Any patients who wants to consider HIFU as a form of treatment for localized prostate cancer would be wise to discuss this with one of the relatively small number of specialists who have been well trained and who have had time to develop their skill and experience in the use of this technique.

6 Responses

  1. “Significant side effects”, bah hum bug, very rare and over reported (fake news!). This incorrect propaganda is the only adverse info on HIFU, read what all the patients say who have actually had HIFU (if you can find it, as HIFU patients are deleted and banned from most cancer web sites) and literally no one would opt for some other treatment, which does have significant side effects”. If we cannot get HIFU we are better off doing nothing.

  2. Dear Don:

    What rubbish. Please tell that to the patients who had excellent erectile function prior to their HIFU treatment and then didn’t. And I know of no patient who has been “banned” from any patients forum.

  3. I don’t think that focal HIFU as a primary therapy should be administered outside of a carefully conducted clinical trial where the patients have to read and sign a document demonstrating informed consent of the risks. Patient-directed advertising touting unsubstantiated claims should be prosecuted.

    Among the many risks associated with it are the controversial “index tumor” theory it’s based on, incomplete ablation in the ablation zone due to the heat sink effect and protective bystander effects, inability to adequately define the target with MRI, undetected satellite tumors, safe and unsafe locations to target, damage to organs at risk, “re-do” rates, methods for tracking progression after therapy, salvage therapies, whether it’s any better than active surveillance in low-risk patients, whether it’s any better than, say, SBRT in intermediate-risk patients, dangers associated with the procedure itself, the role of experience in practitioners, the cost of the procedures. Most patients who rush into this don’t even know that these are unresolved issues. Without long-term data on all these open questions, patients cannot make an informed judgment.

  4. I know (on line) 14 who had HIFU. None had any side effects at all. They also know others.

    I personally have been banned several times from every cancer site I could find. This is the only site that hasn’t banned me. All I said was the word HIFU, and something positive. Healingwell is the quickest site to ban. Once I said it didn’t work for me to see if they would ban me, they didn’t, what a coincidence.

    Some people were mad at me because it costs so much, I felt bad for them, but they shouldn’t be mad at me. I was even banned from a women’s forum. It’s been 10 years since I had my treatment. The worst part of HIFU is the patient cost. And the fact that no one cares about the outcome because there is too much invested in robotic and radiation, not much to invest into HIFU.

    No drug manufacturer will ever invest in a clinical trial when there are no drugs or need to even put the patient to sleep for the treatment. And no HIFU doctor has the cash to run a clinical trial.

    Produce one man who says HIFU ruined their function here, just one! I won’t believe it until I read one.

    There are several guys here who had HIFU who post here. I haven’t read one who is unhappy.

    When I was first banned, and I got a pop up which said, “You’ve been banned from this site”, I was sick to my stomach. I thought I came with wonderful news and everyone would cheer, instead, one post and gone.

  5. Dear Don:

    The side effects and complications associated with the use of HIFU have been reported in multiple scientific and medical papers and in documentation provided to the FDA and other regulatory agencies by the manufacturers of the equipment. HIFU certainly works very well for some men. So do lots of other treatments. They all still come with risk for complications and side effects.

    I did the very simplest of on-line searches to find an unhappy patient within seconds. And here’s a link to data on the outcomes of > 500 HIFU patients treated at one of the most respected prostate cancer treatment centers in Europe. Note that only 25.4% of the men who were sexually potent prior to treatment were sexually potent afterwards! The fact that you have “met” 14 patients on line who claim to have had excellent outcomes doesn’t mean a thing. I can probably find you hundreds of men on line who claim to have had wonderful results after nerve-sparing surgery and various forms of radiation therapy too.

    On the other hand, I am delighted to hear that your treatment went well. … But that doesn’t mean that everyone else’s did.

    And HIFU actually isn’t particularly expensive — when you compare it to the cost for — say — proton beam radiation therapy (which some other men imply has few to no complications or side effects, but that isn’t true either).

  6. My urologist (I’m relatively close to Toronto, Canada) said he has had three patients who have had HIFU. This treatment is not covered by our free medical care here, but is available, for example, at a private Toronto clinic at a cost of around CAD$15,000 to CAD$20,000.

    Results of all three of this urologist’s patients who opted for HIFU were bad.

    One problem with HIFU, he said, is that good candidates for HIFU are, generally speaking, also good candidates for active surveillance (AS). Hence the problem of choosing HIFU (with its cost, side effects and risks) vs AS (no costs or side effects and few risks).

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