The misleading promotion of HIFU as a treatment for prostate cancer


We were recently made aware of a video on Facebook promoting high-intensity focused ultrasound (HIFU) as a treatment for prostate cancer. The video promotes the services of a particular group of physicians who specialize in this form of treatment. They are, of course, entirely entitled to do this.

Now your sitemaster wishes to be very clear — right up front — that he believes HIFU may well be a highly appropriate form of first-line therapy for some men with some forms of early stage prostate cancer (and it may also be an appropriate form of second-line therapy for some men with some forms of progressive disease after first-line radiation therapy). He is also aware that HIFU can be used appropriately in carefully selected patients as a form of focal therapy for prostate cancer. Indeed, he actively recommends discussion of HIFU with experienced HIFU providers to some patients. However, your sitemaster also finds the promotional approach that is being used by the provider group in question to be distasteful, inaccurate, and misleading, and he would caution men considering HIFU as a form treatment for any type of prostate cancer to ask very hard questions of any provider about reasonable clinical expectations.

Why?

Because here is what is not mentioned on the video (although some of the items are mentioned on the provider group’s web site):

  • There is no clear statement that HIFU has not been approved by the FDA for the treatment of prostate cancer. The video does state that HIFU has been approved for the “ablation of prostate tissue”, which is accurate. Most newly diagnosed patients will not really understand this careful and important distinction.
  • There is no clear statement that the patient will be responsible for many of the costs associated with this form of treatment that are not covered by Medicare or by any commercial insurance company.
  • There is no clear statement that current guidelines from the American Urological Association (AUA), the American Society for Radiation Oncology (ASTRO), and the Society for Urologic Oncology (SUO) do not recommend HIFU as a treatment for prostate cancer; in fact, these guidelines state very clearly the things that patients should be made aware of about the use of HIFU in the treatment of prostate cancer (see recommendations 56 to 60)
  • There is no clear statement that the same set of guidelines — and the guidelines issued by the National Comprehensive Cancer Network (NCCN) — now state that active surveillance is the most appropriate form of initial management for men with very low-risk disease (see recommendation 7) and is a recommended form of management for men with low-risk disease (see recommendation 8).
  • There is no clear statement about the side effects and complications associated with HIFU (used either as a focal or a whole-gland procedure) as a treatment for localized prostate cancer. These complications and side effects are known to have included
    • The necessity for repeat procedures (which the patient would again need to pay many of the costs for, unless there is a clear statement from the provider that he/she will cover all costs associated with such repeat procedures)
    • The occurrence of post-operative urinary tract infections (short-term and recurrent)
    • The need for subsequent endoscopic interventions (for a whole range of possible reasons)
    • The occurrence of epididymo-orchitis
    • The very rare occurrence of recto-urethral fistula (basically, the development of a hole between the urethral and the rectum)
    • The common occurrence of significant loss of erectile function compared to baseline function in men who had good erectile function prior to treatment (although complete erectile dysfunction after HIFU is rare in men who had good erectile function prior to HIFU)
    • The occurrence of some degree of urinary incontinence (i.e., the continued use of urinary pads over time) in a small percentage of men treated by HIFU

The point here is that: (a) HIFU is not always effective as a treatment for prostate cancer and (b) it is not always safe in terms of the risk for complications and side effects. Many carefully selected patients will do very well; others may have real problems. And it is also imperative to appreciate that the men who will do best after treatment with HIFU may well be the men who never really needed treatment in the first place because they would have done just as well (or actually better) on active surveillance.

If HIFU was a drug being promoted by a pharmaceutical company, the manufacturer would be required to provide full details about the complications and adverse effects associated with its use and the manufacturer would be required to provide complete data about the outcomes of the drug in clinical trials. The same is true for the manufacturer of the equipment that this group of providers state that they use in treating men with HIFU. No such information appears in this video or on the provider’s web site. Nor are there any data about the outcomes achieved by this particular group of physicians in treatment of men with prostate cancer (although such data are rare for pretty much all physicians treating prostate cancer in any manner whatsoever).

The one thing that The “New” Prostate Cancer InfoLink would definitively praise the provider group for doing is explaining exactly what is and what is not covered by Medicare and other payers in relation to the use of HIFU in the “ablation of prostate tissue” (see here). The only thing that Medicare covers is the actual operational costs of the approved facility (hospital, outpatient facility, etc.) where the procedure takes place (which can not be just a physician’s office). Thus, under Medicare, when the HIFU procedure is done at an approved facility, the patient is still responsible for all of the following:

  • The time of the physician who performs the HIFU procedure (and the time of any and all associated clinical support staff)
  • The time of the anesthesiologist who administers anesthesia (and perhaps a certified and registered nurse anesthetist or CRNA)
  • Any and all follow-up patient care and support services post-treatment

As far as your sitemaster is currently aware, almost no commercial insurance provider covers even the facility costs associated with treatment of prostate cancer using HIFU.

The “New” Prostate Cancer InfoLink has long been disturbed by the way that some hospitals and provider groups have gone about the promotion of specific forms of treatment for prostate cancer over the years. (The way that robot-assisted laparascopic surgery was promoted in the past was particularly sad.) However, he had hoped that, with the coming of understanding that active surveillance is probably the most appropriate form of first-line management for as many as half of all men being diagnosed with prostate cancer in America today, we would see the promotion of specific forms of treatment placed in a more appropriate context and with fuller disclosure of the risks as well as the benefits of each form of treatment. This is particularly the case when the treatment in question has not even been approved for the treatment of prostate cancer!

 

11 Responses

  1. Thanks for the analysis. Also, a TURP may be required with anesthesia, catheter, infection risks, retrograde ejaculation risks … and you will not be a good candidate for low-dose seeds post-TURP.

  2. Those of us with our disease are constantly exposed to those seeking our money by investing in “the latest” technology to offer treatment. Too often this is without the advertisers having the needed experience to use it effectively, or safely. Those in the UK and Europe that successfully use HIFU stress the need for substantial training and experience to use it correctly. It is very operator dependent, requiring experience and skill to correctly interpret the ultrasound imaging to accurately focus the high-intensity energy.

    As is the case for daVinci/robotic surgery, if one wishes to pursue HIFU, be sure to require clear evidence that the clinic offering it has substantial and successful experience in using it for prostate cancer.

    “BUYER BEWARE!”

  3. I haven’t seen the video in question, but I’m not sure that they are legally allowed to promote HIFU as a prostate cancer treatment. I thought that the FDA had been cracking down on web sites where doctors had promoted such off-label use.

  4. As with anything, people who know the truth about HIFU have a hard time not spreading the good word about it.

  5. Don:

    I’m truly glad HIFU has worked for you. Here’s the “truth” as another patient told it:

    “HIFU #1 in 10/2010: Entire gland and both SVs ablated. PSA was undetectable for just over 6 months and then started to rise. When PSA breached 1.0 in 2014, had a high resolution mpMRI. MRI showed no evidence of disease. Went ahead and had a traditional biopsy done which found a couple of low volume cores of 4 + 3 and 3 + 4 on the tip of left side.

    “HIFU #2 in 9/2014: Only the left side, where the 2014 biopsy cores were positive, was ablated. PSA was undetectable for just over 6 months and then started to rise. Doubling time is recently under 6 months with a velocity of 1.0 per year. Present PSA = 0.74. Time series of PSA over number of days is very similar to the profile after HIFU #1 except a little steeper for the most recent measurements.

    “C11 Carbon acetate scan just done and showed no signs of metastasis. There was activity on the right side at the boundary of the original prostate.”

    That patient has just had his second salvage procedure after two HIFU failures (whole gland at first and salvage hemi-gland). He chose salvage SBRT this time. Incomplete ablation in the ablation zone is certainly an issue. We have to understand the phenomenon before it can be endorsed outside of clinical trials.

  6. Dr. Mark Emberton (London expert) on Whole Gland HIFU: Don’t Do It!

    Many of us who have been following HIFU over the years with steadily waning enthusiasm are aware that Dr. Mark Emberton, an eminent HIFU expert physician and researcher at University College, London, UK, has been a HIFU pioneer and heavily involved in published research on HIFU. I think it’s safe to say that he is one of the world’s most experienced and savvy doctors in the use of HIFU coupled with disciplined observation of its follow-up levels of success or failure as the years go by. Indeed a publication last fall concluded, based on medium-term follow-up, that cancer control with HIFU was “acceptable”, coupled with side effects comparable to more established therapies. (Notwithstanding the “acceptable” descriptor, many of us would view the results by risk category to be non-competitive with major therapies and rather discouraging at “just under 5 years of follow-up.”)

    However, Dr. Emberton was listed near the end of 17 authors on that paper, and I suspect, based on his startling statements at a conference last September, that his participation mainly involved follow-up for patients he had treated.

    At that September 2016 conference, Dr. Emberton was the plenary session presenter for a talk billed as “Focal therapy and HIFU” (the 2016 Conference on Prostate Cancer sponsored primarily by the Prostate Cancer Research Institute and Us Too). I’m sure a lot of us were wondering what he would say in favor of HIFU, given the context: (1) that an FDA advisory committee had recommended twice within the past 14 months against FDA approval of HIFU as a treatment of prostate cancer (while oddly approving it for non-specified “prostate ablation”, and (2) that research results from centers around the world were consistently showing non-competitive cancer control by HIFU once patient follow-up got beyond 3 to 4 years, with one encouraging exception in Japan (the Uchida team, late July 2016).

    He caught our attention when he stated at the outset, “I’m not really going to talk about HIFU. I’m going to be talking about treating people differently when the cancer is confined to the prostate” (DVD Disk 1 52:50). He went on to talk about focal therapy, especially the role that mpMRI was playing in treatment decisions for prostate cancer that was apparently confined to the prostate. That said, as a highly experienced HIFU practitioner, he had some stunning things to say about HIFU for whole gland therapy, and here’s the gist.

    In his Question & Answer with moderator Dr. Mark Moyad, MD, he stated “I haven’t done a whole gland treatment for 8 years” (Disk 1: 1:41:15). In Q&A with patients he stated “I don’t do whole gland treatment with HIFU anymore. I don’t think HIFU is a good way to treat at the whole gland level; you might as well have surgery or radiotherapy. Why, because HIFU creates a lot of scar tissue. And provided you are away from the key structures, that scar tissue is not a problem. But if you’re trying to turn a 40 cc gland into a 4 cc gland, that’s a lot of tissue the body has to absorb and turn into scar tissue, and that does have effects on strictures, on erectile function, and indeed, continence. So I wouldn’t use HIFU for whole gland” (Disc 3: 2:09:08 – ~2:10). In a Q&A exchange with Dr. Moyad, the pair noted that prostate tissue can be fibrotic after receiving energy, and that can make for an “ugly [salvage] surgery. The ugliest …” (Disk 1: ~1:42:30 – 1:44:03).

    He also mentioned some technical limitations of HIFU as a whole-gland treatment. He noted that, “HIFU has this fixed focal length, and when you’re treating the whole prostate, the whole prostate has to fit within your 4 cm [40 mm] focal length” (Disk 1: 1:41:59 – ~1:42:20). Regarding disease outside the capsule, he said that, “HIFU is not a great energy source for treating outside the capsule. So if someone was [stage] T3a or T3b, I would normally recommend surgery or radiotherapy, or cryotherapy because you can grow the ice ball outside the prostate, where sound energy [HIFU] is going to scatter. Outside the prostate you’ve got fat, typically, which absorbs a lot of the energy. HIFU is not a good energy source for T3a or T3b disease” (Disc 3: 2:07:15 – 2:07:54). He noted several biological factors that at times could lead to HIFU failure: “Obviously sound waves scatter: calcification, movement, swelling, blood supply are all working against you to take that heat [from HIFU] away to other parts of the body” (Disk 3: 2:05:13 – ~2:05:45). Minutes earlier he had noted that, “if there is calcium in the prostate, you wouldn’t use ultrasound — it’s like hitting a brick wall” (Disk 3: ~ 2:02:30). (I would really like to see a discussion between Dr. Emberton and Dr. Uchida on whole-gland HIFU. I’m curious whether Dr. Emberton judges that the Uchida team has conclusively made a breakthrough with the special suite of technologies it uses in its apparently successful HIFU work on the whole prostate.)

    While Dr. Emberton is clearly now opposed to using HIFU for whole-gland therapy, he also is still enthusiastic about it as one of a number of possible focal therapy tactics, depending on the patient’s particular circumstances. In addition to HIFU for focal therapy, he also commented on cryotherapy, radiation, electroporation (Nanoknife®), laser, photodynamic therapy (TOOKAD®, investigational), and perhaps another one or two tactics that I have overlooked in this review. I found his comments on focal therapy most impressive, though wanting a bit more follow-up time in research.

  7. Wow Jim, you are a serious resource.

    Emberton around here (London, and perhaps globally) is to focal HIFU as Klotz is to AS. But speaking in my wholly lay position of being a statistically insignificant sample set of one, I have reached a conclusion.

    I reckon focal HIFU is best seen as a placebo for rich (or study-lucky) Londoners on AS. And I’m not sure it’s not worse than that, i.e. it looks to me that you can muck about with Gleason pattern 3 pretty much at will but I am more cautious on 4 (and I am pretty sure they don’t touch 5). On, again, an insignificant sample set of one, a mate of mine had his 4 + 4 (!) treated with focal HIFU at one prominent London teaching hospital. After a follow-up MRI (whose results were allegedly mislaid, causing a delay), he had an urgent RP at another prominent London teaching hospital, at the (robotic) hands of the gentleman who, if anyone, will do mine one day.

    So for now I am keeping my Gleason pattern 4 (for now, nicely wrapped in 3) and the gene fragments Klotz talks about right where it is, and hopefully under some metabolic stress, rather than bursting it into my bloodstream.

  8. “As far as your sitemaster is currently aware, almost no commercial insurance provider covers even the facility costs associated with treatment of prostate cancer using HIFU” — this may be true in the US, but certainly not with health insurers in the UK.

  9. The Sweet Spot for HIFU and Other Focal Therapy

    Hi UnreasonableMan — I like your name.

    Dr. Emberton addressed precisely the area you were concerned about in your comment that: “… I reckon focal HIFU is best seen as a placebo for rich (or study-lucky) Londoners on AS. And I’m not sure it’s not worse than that, i.e. it looks to me that you can muck about with Gleason pattern 3 pretty much at will but I am more cautious on 4 (and I am pretty sure they don’t touch 5). …”

    He sounded convincing when he said that focal therapy should not be done for either good candidates for active surveillance or for men who really needed whole-gland (and perhaps more) treatment; rather, it was suited for the sweet spot in between. It was abundantly obvious in his talk that the emergence of reliable and precise multiparametric MRI technology has played a critical role in enabling effective focal therapy. (By saying “effective”, we are giving focal therapy the benefit of the doubt as follow-up is still a bit on the short side.) Indeed, he emphasized the role of mpMRI in avoiding unnecessary (and ineffective) biopsies as well. He concluded his talk with this statement: “So some men don’t need treatment; some men need a lot of treatment, and in the middle there are men who can get away with very focal treatment.” (Conference DVD Disk 1: ~1:24:50)

    He got into this in more detail in the Q&A session with patients, talking about mpMRI “PI-RADs” scores, with PI-RADs units from 1 to 5 indicating the seriousness of the cancer: “… I think it’s pattern 4 that is the challenge. So if Gleason [pattern] 3 doesn’t kill you, and [Gleason] pattern 5 is rare, it’s really about how much pattern 4 you’ve got. I think if you’ve got pattern 4 — and there’s evidence from two active surveillance studies now [that] you’ve got high progression rates, and they can see it, I think that’s a very good rationale for ablating it. I only treat pattern 4. [Pattern] 3 we watch. [Pattern] 5 I often recommend for multimodality [treatment] because it’s often metastasized, but I’m happy to treat [Gleason] 4 + 3, 3 + 4, provided I’ve got a nice target.” (Disk 3: ~2:36:40 – 2:37:39)

  10. I don’t understand how, if HIFU has not been approved by the FDA for prostate cancer, practitioners are able to advertise and employ it for that purpose.

  11. Dear Cliff:

    Physicians have enormous freedom to both treat their patients as they see fit (whether a particular form of therapy is “recommended” by their specialty organizations or approved by the FDA or not) once a product is approved for any form of use. They also have enormous freedom to promote their services now that they have been freed from the much older “ethical” guidance that no physician (and no lawyer either for that matter) should promote their services.

    Thus, it is not illegal for a physician group to promote the use of HIFU to treat prostate cancer. Whether it is morally or ethically appropriate is a whole other matter. In my entirely personal opinion, any physician group doing this needs to be extremely clear and transparent about all of the known facts about the use of HIFU in the management of prostate cancer.

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