HIFU outcomes in Germany after an average of 8 years of follow-up


Researchers at the University of Regensburg in Germany have just reported progression-free survival data from their 14-year experience of using high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. This research group was one of the first to start testing the use of HIFU in the treatment of prostate cancer.

According to this new paper by Ganzer et al., their report is based on data from 538 consecutive patients who received HIFU as first-line treatment for clinically localized prostate cancer between November 1997 and September 2009. The report provides information about biochemical progression-free survival (bPFS) according to the Phoenix criteria (a PSA nadir + 2 ng/mL); metastasis-free, overall, and prostate cancer-specific survival; salvage treatment; side effects; potency; and continence status. It is our understanding that most if not all of the patients treated at Regensburg have, in fact, been treated with the Ablatherm HIFU technology, which has been through a series of evolutionary improvements over that 12-year period.

Here are the core results reported by Ganzer et al.:

  • The average (mean) follow-up was 8.1 ± 2.9 years (range, 2.1 to 14.0 years).
  • The overall actuarial rates of bPFS rates are
    • 81 percent at 5 years
    • 61 percent at 10 years
  • For men with low-risk prostate cancer, the actuarial bPFS rates are
    • 88 percent at 5 years
    • 71 percent at 10 years
  • For men with intermediate-risk prostate cancer, the actuarial bPFS rates are
    • 83 percent at 5 years
    • 63 percent at 10 years
  • For men with high-risk prostate cancer, the actuarial bPFS rates are
    • 48 percent at 5 years
    • 32 percent at 10 years
  • Rates of actual metastasis-free survival were
    • 99.6 percent in men with low-risk prostate cancer
    • 94.3 percent in men with intermediate-risk prostate cancer
    • 84.6 percent in men with high-risk prostate cancer
  • 18 percent of the patients required salvage treatment
  • 75/538 patients (13.9 percent) died from all causes during follow-up.
  • Prostate cancer-specific deaths were recorded among
    • 18/538 (3.3 percent) of all patients
    • 0 percent of men with low-risk prostate cancer
    • 3.3 percent of men with intermediate-risk prostate cancer
    • 11.0 percent of men with high-risk prostate cancer
  • Side effects reported include
    • Bladder outlet obstruction ( in 28.3 percent of patients)
    • Stress urinary incontinence (of grades I, II and III in 13.8, 2.4, and 0.7 percent of patients, respectively)
    • Recto-urethral fistula (in 0.7 percent of patients).
  • 25.4 percent of patients who were potent prior to their treatment were able to preserved potency.

Ganzer et al. conclude that their study “demonstrates the efficacy and safety of HIFU for localized prostate cancer” and that “HIFU is a therapeutic option for patients of advanced age, in the low- or intermediate-risk groups, and with a life expectancy of ∼10 years.”

While this conclusion is certainly a reasonable one, there are also some problems with it (in the opinion of The “New” Prostate Cancer InfoLink):

  • In the first place we have no idea what percentage of the men with low- and intermediate-risk prostate cancer may not have needed treatment at all within 10 years of diagnosis. In other words, what percentage of these patients would have had a similar therapeutic outcome on active surveillance?
  • Secondly, a 37 percent biochemical progression-free failure rate among the men with intermediate-risk disease is hardly an outstanding success rate (although we acknowledge that at least a proportion of these men could probably have been — and maybe were — successfully re-treated with HIFU).
  • Third, only 25 percent of the men who were potent prior to treatment were able to recover potency post-treatment (which is similar to the rates of recovery of potency post-surgery).

The authors are careful to point out that there are still “conflicting recommendations for HIFU among urological societies, which can be explained by the lack of prospective controlled studies, reports on preselected patient populations and limited follow-up providing little information on overall and cancer-specific survival.” This is a fair comment.

We should also point out that since the Regensburg patients series extends back to use of the earliest types of Ablatherm technology, outcomes of men treated in the recent past may well be better than those of men treated early on. As an example of this, we believe that occurrence of recto-urethral fistualae among men treated with HIFU today is almost unheard of, and that the four cases in the Regensberg series all occurred very early in the application of this technology.

The things that we feel need to be made very clear to patients considering HIFU is that even for those men with good potency prior to treatment, HIFU is associated with a significant risk for post-treatment erectile dysfunction and, in addition, about 25 to 30 percent of HIFU patients will have significant bladder outlet obstruction post-treatment as prostate tissue dies off.

We have said this before and we will say it again for emphasis … Like every other form of treatment for localized prostate cancer, HIFU is associated with a significant level of risk for complications and side effects.

We would also make one other, final comment. … It does seem odd to us that in 14 years the physicians at Regensburg have only been treating an average of about 38 patients per year since they started using HIFU to treat prostate cancer in 1997. One does wonder whether such numbers represent a high level of confidence in the applicability of this technique to most men with low- and intermediate-risk prostate cancer at Regensberg itself.

30 Responses

  1. Re: “I have said it before and I’ll say it again”: HIFU results are exactly dependent on the competence of a high volume urologist just like radiation and RALP. HIFU data in the US is minimal since the FDA is still going through the approval process.

    In the next 10 years we are hopefully going to see a real comparative analysis of all treatments complete with cogent data. Such data are not currently provided to patients by the medical community.

    HIFU continues to be the prostate cancer whipping boy in urological treatments. Generic data and opinions seem to stereotype a little too much. Maybe we should go back to 1997 and document fistulas, impotence/incontinence from radiation.

    But having read this, and now being 10 months out of HIFU, there is considerable reason for optimism … and if I had it to do all over again, I would never chose RALP or radiation. It’s going to be interesting to see what the HIFU market share will be in 10 years. Will patients choose to put radiation in their bodies, to have surgery, or to chose a less invasive procedure for low- or medium-risk disease?

  2. Elucidated1:

    What have your prostate cancer results and side effects from the HIFU been? Who did your HIFU?

    Doug

  3. I had my HIFU on April 13, 2012. It was outpatient and I was back at the hotel eating room service that night. I have no incontinence or impotence. My PSA continues to drop and is now 0.3. The other men who were with me in Bermuda have the same results. I was playing golf and softball a month later.

    I researched the snot out of all of the treatments. I chose doing HIFU with Dr. Stephen Scionti from Boston. I wanted someone who is anal and a perfectionist. Dr. Scionti is. He gave me his cell number and if I call him, he picks up, if that tells you anything. Dr. Scionti is a HIFU proctor for the FDA and is probably the most experienced HIFU doctor in the US. I cannot rave about my experience enough. Click here to e-mail me and I can share more.

  4. Elucidated1:

    Did you have yours done with the Sonablate device or the Ablatherm device mentioned in the study?

    Ron

  5. Ron,

    I researched both Sonablate and Ablatherm but chose Sonablate for several reasons, as well as Dr. Scionti.

    E-mail me and I can tell you more. I just got to Arizona for spring training but can keep in contact if needed. I am not paid by anyone. Just passionate about how well my experience went.

  6. I also had treatment by Stephen Scionti, only 4+ years ago.

    the Ablatherm in Germany always gives a TURP prior to treatment, I wonder if this cutting procedure isn’t responsible for the ED.

    Although I find most patients who had treatment years ago with the Sonablate, like I did, experienced some ED for a month and up to a year after. But, no one had lasting effects, and Cialis worked great.

    BTW, I am a different Ron than the one who posted above, not capitalized R.

    HIFU is the best treatment, it’s a crime it isn’t approved.

  7. Huh? You mean there is more than one “Ron?!”

    HIFU will be approved. Like you, I am pretty happy. Last year at this time I had cancer.

    Today I am playing golf in Arizona at a killer course and not going to look back. Too bad so many prostate cancer patients don’t have the same results as you and me.

  8. I know quite a few men who have been treated with the Sonablate HIFU and all have our results. I tell everyone I meet about it. I even know two who had the Ablatherm and one had great results. One went to the doctors mentioned in the study and was unhappy with his side effects; it’s been a while since I talked with him now, so I don’t know how it’s going, but his PSA was 0.01.

    Men who cannot afford it get angry when they hear about it. … The FDA can’t approve it too soon. But I am not as optimistic as you. I think they will hold it back as long as is humanly possible.

  9. Dear Ron:

    I am sorry, but your comment above appear to show that you do not understand how the FDA works at all.

    The FDA has absolutely no interest whatsoever in “holding back” any product or treatment that demonstrates a clear benefit to patients relative to the risks involved in its use. Either the sponsor (the manufacturers) have demonstrated such a relative benefit or they haven’t. That’s why they are asked to do clinical trials.

    Having said that, I will state clearly that I am not (yet) as convinced as you are that the data provided to the FDA by the manufacturers will be as compelling as your perception of your personal outcome. All the data that have been published on HIFU to date suggest that men with clinically significant prostate cancer (as opposed to men with low-risk disease who may not need treatment at all anyway) have a significant rate of relapse after HIFU along with significant risk for a range of side effects. The FDA is not going to approve either the Sonablate or the Ablatherm devices on the basis of the excellent results that certainly are seen in some patients. They also have (by law) to take account of the significantly less excellent results that are observed in others.

    The few really detailed and published studies clearly suggest, also, that physician experience with HIFU therapy is a critical factor — just as it has been for every other form of treatment.

    This does not, for one moment, mean that I don’t think HIFU shouldn’t be approved. If it meets the benefit/risk standard required by the FDA, then I am all in favor of its approval, along with a rigorous training program for its use so that we don’t just get a bunch of cowboys rushing out and HIFU-ing people who may not need treatment at all anyway.

  10. Sonablate documentation submitted from SonaCare Medical for FDA approval was 10,000 pages long. FDA Clinical trials for HIFU for total ablation as well as recurrent cancer have gone on for years in multiple universities and continues.

    Current radiation devices as well as da Vinci all got grandfathered in for FDA approval and did not have to go though FDA hoops. I believe it was around 2003 that RALP was allowed.

    Yet even though there have also been “significant less excellent results” from both radiation and RALP, it’s compelling that current prostate cancer patients seem impotent (pun intended) to collect and review results from clinics, hospitals, and individual physicians for said procedures.

    At what point in time do all prostate cancer procedures face equal scrutiny and transparent exposure of success as well as side effects? If the argument against HIFU suggests mistakes or incomplete data, then how can we tolerate little published success/failure rates and side effects for radiation and RALP?

    And after a decade of RALP, why can’t current prostate cancer patients Google said cogent data since it is approved by the FDA? Or is transparent accountability an oxymoron in the urology community?

  11. Dear Elucidated1:

    Oh puuh-leazze. … There is no “transparent accountability” in medicine. Why? Because it is all driven by financial considerations at some level. If you think this is exclusive to the urology community, you really need to “get out more.”

    And with respect to the documentation submitted for approval of HIFU, the average drug application runs to between 50,000 and 100,000 pages as opposed to 10,000.

  12. Go ahead and cite your source that the average prostate cancer patient can easily find published data on the success and failures of their urologist, their hospitals, etc. We’ve already discussed the fact that is no comparative data on radiation, RALP, etc. Maybe that can be the source of the next missive. And who IS the best prostate cancer patient advocate in the country?

    With 240,000 Americans diagnosed a year, we should be able to bring up procedure results easily, right? But this website is proof that US patients have difficulty researching which treatment is appropriate for their individual situation. That is one of the reasons this site is so great.

    Since you apparently have urologists reading this blog … it should also be easy to see a report card for just one urologist or is there a reason that, generically, they don’t publish their data and share it with patients?

    I would like to see national data on which PC procedures are most recommended and by whom and the results and side effects.

    2. I didn’t realize length of application was a precursor for FDA approval. Thanks.

    3. My prostate cancer took me to several urologists and not one would provide, on paper, their report card. But I can go on yelp and figure out the quality of a restaurant or hotel. What is wrong with this picture?

    4. Last week I was in AZ and watched baseball, played golf, and ate breakfast next to the table that Sheriff Arpaio frequents and orders plain pancakes. Does that count for getting out more? BTW, he couldn’t make it last week. . .seem to have a fall and broke his shoulder.

  13. Dear Elucidated1:

    I am not aware of any searchable database providing independently validated outcome data for the treatment of any clinical condition — whether treated surgically or any other specific way, whether en masse or by a single physician (surgeon or any other clinician). As you well know, we have regularly proposed such registries. If and when Ablatherm and Sonablate can get HIFU approved by the FDA, do you seriously expect them to insist on providing a HIFU registry that all HIFU physicians will be asked to contribute data to? Who will provide the independent validation agency?

    How do you define “best advocate”? My point is that this lack of independently validatable data has nothing to do with prostate cancer specifically. It is an endemic problem across the entire field of medical practice, and is why we have no really good data on the comparative effectiveness of differing treatments for the vast majority of disorders unless actual head to head clinical trials get carried out. And this is exactly why the FDA has insisted on clinical trials of new technology like HIFU — trials which have historically been avoided by the medical device industry through the use of Section 410(k) approval. In many, many ways the FDA is actually one of every patient’s best advocates today because it insists on clear demonstration of data to show that products are sufficiently effective and sufficiently safe before they can be brought to market in America. Is the FDA perfect? Of course not. It is run and operated by people. People make mistakes, disagree with each other, can have very strange opinions, and screw up frequently!

  14. As a recent post-HIFU patient, I’m alarmed by the comments and data presented by the HIFU-hostile lobby. However, this alarm is offset by noting the absence of comparisons with the prognoses and all too common side effects linked to established treatments. This strikes me as disingenuous at best.

  15. Brendan, like you, I also found the hostility for HIFU early on. And what most amazing to me was that the most harsh critics had never witnessed or performed HIFU and had absolutely no data to support their position.

    At the last AU conference, though, in San Diego, the HIFU booths were packed with doctors, looking down the road as Sonablate and Ablatherm become FDA approved and will eventually be one more less invasive solution for prostate cancer patients in the US.

    Just wait until the health insurance companies figure out that proton therapy costs $125K, RALP costs $75K … and yet HIFU only costs $25K …. We will see some changes in how we deal with prostate cancer.

  16. Dear Brendan:

    Since we still have no good long-term data from a single randomized clinical trial of HIFU, we don’t believe that the “pro-HIFU” lobby is any more justified in its opinions than the “pro-surgery”, the “pro-proton beam”, the “pro-RALP”, the “pro-CyberKnife”, or the pro anything else lobbies. Every form of invasive treatment for localized prostate cancer comes with risk for complications and side effects.

    Many of the men who do best on all of these forms of treatment have low-risk forms of prostate cancer that quite certainly appear to be easily manageable and well-managed with careful monitoring (and deferred therapy as needed) as opposed to any form of immediate intervention.

    We are no more “hostile” to HIFU than we are to any other form of first-line treatment for localized prostate cancer. We just think that far too many men are being “sold” on treatment when they are at their most vulnerable, and that the best available data on HIFU shows that (a) it has significant side effects in a subset of patients and (b) it has relatively high risk for recurrence in the men with intermediate- and high-risk disease who probably do need really treatment.

    If you can provide data that refute this, we are listening. However, you need to appreciate that we regularly advise low-risk patients who want to get immediate treatment that HIFU is an option (if they can afford it). We tell them that, if they want HIFU, they should make very sure they get it done by someone who has a real track record and experience in the use of this technique (because it takes time to learn to do well, like every other form of treatment). We tell many of them that active monitoring may well be all they really need, and that they should look into it … which is a whole different issue. We tell any patient with intermediate- or high-risk disease according to the D’Amico risk criteria that such patients, when treated with HIFU, have a relatively high recurrence rate. There is a critically important distinction between telling people that things exist and actively recommending them. We do not actually “recommend” any form of treatment to any patient. We simply try to provide them with the best data that are available.

  17. Dear Jim:

    Respectfully, I can assure you that no insurance company is paying anyone $75,000 for a RALP or $125,000 for proton beam radiation therapy. The insurance industry is far from stupid! Those are “rack rates” that some high status physicians/hospitals give as their prices to cash-paying customers who are unwise enough to agree to pay them.

    Last time I heard, the reimbursement from Medicare for carrying out a radical prostatectomy was well under $25,000 (inclusive of the OR fees and hospitalization). The commercial insurance providers are certainly not paying much more. If and when HIFU does get approved, the cost of treatment with HIFU will get negotiated like anything else, and a key factor in that negotiation will be the risk for side effects and complications and the rates of recurrence post-treatment.

  18. Site,

    Again, your responses are always credible and without peer. I would like to know the actually costs for radiation and RALP as well as all treatments for prostate cancer.

    What is quite compelling as the ACA defines costs and treatments, is how the delivery system will provide care without those willy nilly “rack rates” of the past as well as hospital roles in care. As I shared before in the forum, for prostate cancer patients to meander through the minefield of different types of radiation, RALP, active surveillance, etc, without a scorecard or unbiased menu of options is unconscionable and only benefits the physicians. Certainly not the patients.

  19. Dear Jim:

    Trust me when I tell you that there are an awful lot of people (including many physicians and other healthcare professionals) that would like full transparency about the pricing of all sorts of healthcare services in the USA (not just the treatments for prostate cancer). It is my entirely personal opinion that the advent of the ACA is potentially a critical driver in beginning to address this problem.

    At present, however, regardless of who you are, where you are being treated, and by whom, everything is a matter of negotiation against institutional “rack rates”. And the “prices” thrown around by most of the media are usually the highest prices quoted because it is in the interests of the media to “emotionalize” the issue.

    Of course there is certainly a reasonable argument that “the best” physicians ought to be able to charge more for their services than “the worst” ones. As yet I am not aware of how anyone expects to be able to address that particular issue since we have no institutionalized methods for actually tracking data to determine who really are “the best” as opposed to “the worst” physicians!

  20. Nice one. It’s unfortunate that professional “peer review” seems to be an oxymoron in the field of medicine.

  21. “Peer review” isn’t an oxymoron. It’s just that we have no systematic way to convert that “peer review” into unbiased data for the consumer or even for other physicians. The process (like most peer review systems) is rife with personal bias as a consequence.

  22. I find the above arguments extremely compelling, having been diagnosed with prostate cancer myself. One of the greatest benefits of HIFU that I have heard of, and please correct me if i am wrong, is that HIFU is a repeatable treatment, unlike surgery or radiation that seem to be a “one or the other” dead end situation. Is this true? Thanks for the informative website!

  23. Dear Steve:

    (1) HIFU is certainly a repeatable form of treatment — under appropriate circumstances in which re-treatment could be expected to be beneficial (which is not all of the time).

    (2) Radiation therapy is commonly usable following surgery — again, under appropriate circumstances in which adjuvant or salvage radiation therapy could be expected to be beneficial (which is not all of the time).

    (3) Surgery can sometimes be used as a salvage treatment after first-line radiation therapy — but this is a very difficult surgical procedure and is not an operation that even experienced prostate cancer surgeons like to have to carry out. It has high-risk for long-term side effects, and few surgeons do this operation often enough to be able to claim that they are really good at it.

  24. I live in the UK. I have just had a template biopsy following a PSA count of 8.2. The next step is HIFU treatment on an index trial. None of this will cost me a penny. Treatment is on the National Health Service (NHS) so despised by many Americans as “social healthcare”.

  25. Just as for what it’s worth … as of June 2013 NIH in the UK was still saying this procedure should be at the clinical level so sadly elucidated1′s love of blaming the FDA as being ineffective and somehow on the take, at least as of the time he was posting this stuff, other nations were still saying the same thing.

    It’s a shame, I was reading his posts with interest as my husband is very close to using this procedure but then he starts name dropping the crazy sheriff from Arizona and seeing conspiracy where it doesn’t exist. If there is any problem with things it likely stems from constant tax cuts and underfunding of needed agencies — it’s okay, we can afford to pay for the procedure outside of the US, as can elucidiated1, the ones who can’t are the ones who should be complaining but of course, they don’t get the tax cuts … we do.

  26. (1) Uh, Melanie, I’m not sure where you are coming from but to encourage you to go ahead and cite the perceived comment I made that I’m “blaming the FDA as being ineffective and somerhow on the take”.

    (2) I am very happy after doing HIFU and have no side effects. It depends, however, on who does the HIFU. The learning curve is very steep, the same with RALP.

    (3) I’ll be staying in Fountain Hills tomorrow, not far from Sheriff Aripaio’s house. Go ahead and share what your point is.

    (4) I do enjoy political banter … although this might not be the best forum for it, but if Mike approved your post, I love it. Go ahead and post your issues with my political opinions. I’ll be walking into the SF Giants/SD Padres game tomorrow asking if they’ll sell me a beer and a hot dog since I’m gay. What is wrong with that?

    (5) It is my belief that Ablatherm or SonaCare (HIFU) will be approved in the next 12 months. It will take some time for health insurance companies to pay for it. But considering that proton therapy costs $47K (Medicare pays) and a RALP costs $50K plus, HIFU at $25K will eventually look like a deal to the delivery system as well as the insurance companies.

    (6) Your turn, Melanie.

  27. Melanie, Jim:

    There is a fine line between meaningful, opinion-based debate and unhelpful political rhetoric. I respectfully suggest you both avoid the latter on this forum … please!

  28. I am a post-HIFU patient, treated by Dr. Scionti, and was considered in the moderate risk area. I had no side effects after 3 months. Having gone to a class reunion, many of my former class mates had had prostate surgery, and all had serious side effects and major deterioration of life style. After doing the research, I saw very little downside to HIFU. The side effects of surgery, hormone therapy, radiation are all far worse than HIFU. Once it is approved, many more affected men will be able to live lives post-treatment with the cancer being nothing more than a distant memory.

  29. TC,

    How long ago were you treated and has the HIFU worked?

    Doug

  30. Doug,

    I would say that HIFU worked extremely well for me. I had a second follow-up treatment (common in cases of moderate risk as I had, I understand) about a year ago, and my PSA numbers are now 0.3 (down from 4.5 pretreatment). What is difficult to find out but true is that all forms of treatment have a certain recurrent treatment required in a percentage of the cases, similar to HIFU. My current number is very good, and I retain full potency, no problems with urination, no other side effects at all.

    I expect no further treatments. I am nearly 68, and for people in my circumstance (Gleason 3 + 4, stage T1a) I can testify to extraordinary upside (normal urinary/sexual life) and very little downside. Use an experienced doctor to evaluate and do the work. I was with Dr. Scionti, and I could not be more enthusiastic with his evaluation, care, intelligence, technique, and follow up.

    It breaks my heart to see so many people having RALP or radiation which, in a very high percentage of cases, damage the lifestyle of so many men. In many of their cases, this is a completely unnecessary deterioration of their lifestyle.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

Join 1,170 other followers