Outcomes after first-line and repeat HIFU procedures in the UK

In the UK, the team led by Drs Ahmed and Emberton has been meticulous in its collection and reporting of outcome data related to their investigational use of high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer.

In a recent paper available on-line in the Journal of Urology, Berge et al. have provided an update on the morbidities associated with first-line and repeat HIFU procedures from the series of > 350 patients treated by this team of investigators working at three UK-based centers between October 2004 and June 2012. This series of patients does include many men with low- and intermediate-risk prostate cancer and a much smaller number of men with high-risk disease.

All patients were invited to complete validated questionnaires related to continence and sexual function before and after each HIFU treatment. All treatments have been carried out using Sonablate 500 HIFU equipment.

Here are the findings from the team’s complete data registry:

  • 359 patients received whole-gland HIFU as a first-line treatment for localized prostate cancer.
    • Average (median) follow-up after first-line HIFU was 45 months (range, 3 to 93 months).
  • 169/359 patients (47 percent) required no further treatment for their prostate cancer.
  • 60/359 patients (16.7 percent) received salvage treatment other than a repeat HIFU.
  • 130/359 patients (36.2 percent) received a second, repeat HIFU necessitated by biochemical, histological, or MRI evidence of localized residual disease after the first procedure.
    • Median follow-up after repeat HIFU was 27 months (range, 3 to 81 months)
    • 37/130 patients treated with a second HIFU required further salvage treatment other than another repeat HIFU.
    • 19/130 patients treated with a second HIFU required another repeat HIFU.
  • About 66 percent of patients completed questionnaires about urinary function after first-line HIFU.
  • Only 34 to 48 percent of patients completed questionnaires about sexual function after first-line HIFU.
  • About 60 percent of patients completed questionnaires about urinary function before and after a repeat HIFU.
  • About 40 and 60 percent of patients completed questionnaires about sexual function before and after a repeat HIFU.
  • Following the first HIFU procedure
    • 10.8 percent of patients experienced a urinary tract infection.
    • 13.8 percent of patients required a urethral dilatation.
    • 9.2 percent of patients required a bladder neck incision.
  • Following the second, repeat HIFU procedure
    • 3.9 percent of patients experienced a urinary tract infection.
    • 14.0 percent of patients required a urethral dilatation.
    • 11.6 percent of patients required a bladder neck incision.
  • Before the first HIFU
    • 86.0 percent of patients were fully continent (no leaks).
    • 1.7 percent of patients used daily pads.
    • 56.5 percent of patients were potent.
  • After the first HIFU
    • 55.7 percent of patients were fully continent (no leaks).
    • 9.9 percent of patients used daily pads.
    • 49.7 percent of patients were potent.
  • After the first HIFU and before the second HIFU
    • 73.3 percent of patients requiring a second HIFU were fully continent (no leaks).
    • 2.7 percent of patients requiring a second HIFU used daily pads.
    • 56.2 percent of patients requiring a second HIFU were potent.
  • After the second HIFU
    • 55.1 percent of patients requiring a second HIFU were fully continent (no leaks).
    • 9.0 percent of patients requiring a second HIFU used daily pads.
    • 56.0 percent of patients requiring a second HIFU were potent.

It is worth noting that the investigators defined “potent” by using the value of 2 on a scale from 0 to 5, when 2 indicated that the patients reported that erections were sufficient for vaginal penetration “a few times (much less than half the time)” with or without the use of a PDE5 inhibitor like sildenafil (Viagra). In other words, there is no suggestion here that “potency” was associated with a high level of unassisted erectile function most of the time.

It seems clear to The “New” Prostate Cancer InfoLink, based on these data from a group of physicians who have a very high reputation as investigators, that

  • The effectiveness of a single HIFU treatment in the management of localized prostate cancer is relatively low (at just 47 percent in this series).
  • The effectiveness of a repeat HIFU, when needed, is only a little higher (at about 57 percent in this series).
  • HIFU is associated with a significant incidence of post-treatment incontinence.
  • The numbers of men with a high level of erectile function post-HIFU is relatively small (although for many men in this study the lack of good erectile function is clearly age-related).

28 Responses

  1. This will never be approved for use in the US. The success has to be at least as good as contemporary EBRT and with fewer side effects. It appears to fail on both counts here. And the US trials have been going for many years with no future. I say divest yourself of the stock in the HIFU equipment companies.

  2. As I understand it, the companies are currently seeking approval for HIFU in the USA only as a second-line treatment for men who have failed first-line radiation therapy.

    There is certainly an unmet need for an effective and safe treatment for such patients prior to the use of ADT. Whether HIFU can meet that need is a whole other question. I have not seen any data relevant to this use as yet.

  3. This may be the best information to date on this treatment and sadly it shows the treatment is too inferior to warrant strong consideration as an option for men with localized disease.

  4. Maybe I missed it, but it would be nice to separate out low from the intermediate and high risk patients, and see how each category fared separately

  5. John:

    Those data are not available even in the full paper. The data on patients’ Gleason scores, PSA levels, and clinical stages are provided in the full paper, but they are not correlated to the patients’ outcomes. It is possible that the authors are planning on doing this once they have 5-year survival data on a sufficient number of their patients.

  6. I would like to give my experience, as I had HIFU 7 years ago and all is well with me, a PSA of 1.

    ED is common following treatment, daily 1/2 cialis helped me achieve total function again, but it did take almost a year.

    A lot of the data is from 2004, and technique and doctor’s ability has to be taken into account. Surely it approves with time?

  7. Dear Ron:

    Most of the data in this study is not from 2004, although some certainly is. Many of these patients were treated significantly later than that, and this group of physicians has documented the fact that their technique did, indeed, improve with time and experience, particularly in the first couple of years.

    I would also note that although only 53 percent of the patients seem not to have achieved a curative outcome in this series of patients, that also means that 47 percent of patients did achieve a curative outcome.

  8. Although some here seem obsessed to find fault with HIFU with this study, consider the following:

    (1) In my opinion, it is not just the treatment being performed but who is doing the treatment. This study does not show who did the HIFU. One of the issues that puts an asterisk on HIFU being done in Europe is they are less than meticulous when doing HIFU and used early stage technology and software. In the last 2 years the software for Ablatherm and Sonablate is much improved.

    (2) Re: my point on it is who is doing the procedure: Dr. Scionti has only had 5% of patients require secondary/salvage treatment which compares more favorable than foced laser ablation, radiation and surgery. In the past 8 years, Dr. Scionti has only had three patients with leakage out of over 900 HIFU treatments. I came out of HIFU with no incontinence or ED and no cancer.

  9. Dear Jim:

    These HIFU procedures were done with great care, mostly by Drs Emberton and Ahmed, who have very thoroughly documented their procedures in previous papers and both of whom are very highly regarded surgeons with very extensive experience. The other European experience is largely based on Ablatherm experience, some of it using very early forms of the Ablatherm technology. Emberton and Ahmed’s experience is all based on the same Sonablate equipment used by Dr. Scionti.

    We are all still waiting for Dr. Scionti to publish any data whatsoever! There is not a single published paper giving any of his data or even a description of his methodology. If he expects anyone to believe the information you are providing, why is this not published in the medical literature? There is no justification for this at all. And please don’t tell me that this has anything to do with the submissions to the FDA, because that is an entirely separate issue. It is not at all unusual for developers of drugs and medical devices to publish the results of their research prior to any approval by the FDA or other regulatory authorities.

  10. Dear Jim:

    Actually, just to be completely clear about this, from my perspective the failure of Dr. Scionti and the manufacturers of the Sonablate technology to publish a single meaningful set of clinical data on the effectiveness and safety of HIFU in the past 8 years has made me increasing suspicious about whether they have anything like the outcomes data that you believe Dr. Scionti is able to provide.

    By contrast, this is just one of several papers from the Emberton/Ahmed group in the UK, and their papers have consistently reported results that are much more like the results reported by others using the Ablatherm technology. You are going to have to pardon those of us who like to see actual data if we have an increasing problem just accepting Dr. Scionti’s word for the quality of his unpublished outcomes data.

  11. Thanks, Mike. i do agree with your point on published data for SonaCare and would submit the point that I would love to see the same comparative data you seek for HIFU … for FLA, the different types of radiation and open/robotic surgery, both of of which that seem to escape scrutiny at this time.
    I would also like to see documentation that these HIFUs were done “mostly” by Drs. Emberton/Ahmed. I was under the impression that has a staff of several HIFU trained physicians.

    I stand by my comments that HIFU physicians in Europe have not been as meticulous as those done here, as well as the fact that software/technology for HIFU has significantly improved during the last 2 years, as has 3T MRI mapping. If this study is only about the UK, then I would lump them in to my point, too, whether it be Ablatherm or SonaCare.

    You and I, Mike, were panelists with Dr. Emberton on Cure Panel Talk Radio in October and both of us have great respect for him and he has noted the improvements. But if you are saying that Mark Emberton, personally, has professional outcomes of:

    — 10.8 UTI
    — 13.8 urethral dialation
    — 9.2 bladder neck incisions

    and 36.2 patients required salvage/second HIFU (!) then I have a completely different view of Dr. Emberton. Those number suggest that either some of the patients were poor candidates for HIFU, or the care they received for their HIFU physician was professionally compromised.

  12. Mike, I have done my homework on this missive and here is what I believe to be true: (1) Dr. Emberton does not do his own HIFUs. He runs a team of staff that do them. They do not use the newer software and they have made significant mistakes as you can see from the data you provided. And why can some physicians like Scionti have great success and yet Emberton’s team have poor outcomes? And boy, did they?! This is a computerized machine. After these poor data, SonaCare made Emberton’s team come to the US for “retraining.” Ask Emberton about it.

    (2) Ahmed is not a urologist. He was a fellow at the university. He has one year of medical training. Do you really want him doing any treatment on you? British socialist medicine at its best.

    (3) How can it be that Yushida can use the same SonaCare machine and only have a 1.5% incontinence rate and yet Emberton’s team have such poor numbers? The answer is Yushida is smoking hot at HIFU and does his own procedures. Emberton does not.

    (4) I stand by my comments on Dr. Scionti. How can it be that he now does 15 HIFUs a month and yet it is a tiny bit difficult to find any patients that unhappy with the result? That is not a rhetorical question. Wouldn’t you think that his patients would be complaining like mad on YANA, or UsTOO, or NPCI? Why aren\’t they complaining? The answer is that Scionti, too, is smoking hot at HIFU and does each patients HIFU himself. He does 3-T MRI, uses Artemis, understands proximity mapping, and is obsessed with getting it right, every single time. I am one of the happy campers.

    (5) Lastly, I challenge anyone here, from Dr. Chodak to you to vet what I have just posted … to set me straight if you think I am spinning any of it.

  13. Dear Jim:

    Three points:

    (1) All 359 of these patients must have been first treated at least 18 months to 2 years ago to have been included in this database, so the “new equipment in the past 2 years” issue is irrelevant.

    (2) It is my understanding that Drs Emberton, Ahmed, and one other surgeon did all of these procedures themselves, but I don’t have absolute proof of that. Emberton and Ahmed certainly did all of the first 150 or so themselves and I know they went on doing HIFUs themselves long after those data were first reported.

    (3) If I am to beleive what I have been told, then Dr. Scionti and Sonocare do indeed have the outcome data on at least a couple of hundred of his early patients, in which case they should have been published long ago if they were really that good. If they don’t have the data, then their claims are unbelievable anyway. How would they know? No one — anywhere else in the world — has followed HIFU patients and reported their data with the level of meticulous accuracy of the Emberton/Ahmed group, and Sonocare and Ablatherm have ceased all trials of the use of HIFU as a first-line therapy. What is someone like me meant to do except assume that they can’t produce data that would contradict the data published by Emberton and Ahmed. Emberton and Ahmed most certainly set out to demonstrate that HIFU with Sonablate equipment was a highly viable form of treatment for localized prostate cancer.

    I would like there to be much better first=line treatments for prostate cancer just as much as the next guy. However, without data to prove it I am in duty bound to consider HIFU to be at best investigational (as does the FDA). And when the only really meticulously reported data show results like those of the Emberton/Ahmed group, you can’t be surprised when someone like Dr. Chodak makes the comment that he did. Someone needs to “show us the money” (if there is any).

    What would you and others think of me if I suddenly started to say that Dr. X had been treating intermediate- and high-risk men with shaped ultraviolet light therapy for 10 years in Chile, and “all his patients get fantastic results with 99% bPFS, no loss of erectile function, and complete resolution of all other urinary difficulties within 5 days … but no, he can’t actually show you any data?” — even if I did know of 4 patients treated by Dr. X who claim complete resolution of their cancer with no side effects? I would hope you would tell me to “show me the money!”

  14. Jim:

    Even if every word you have written above is 150% accurate, you are still missing my point. Show me the data!

    Actually, you may be helping to make my point, because what you are implying is that, outside a very small number of extremely highly trained, highly skilled, and highly experienced subspecialists, using HIFU does not have very good results, and therefore that its widespread use would result in far more outcomes like those reported by Ahmed and Emberton than those that Dr. Scionti claims but has not published! (We already know this is true for radical prostatectomy, and for cryosurgery, and for brachytherapy!)

    I am making exactly the same request of Dr. Scionti and Sonocare as I would make for any other new form of therapy. It took 20 years before we started to get reliable data about proton therapy. By comparison, we have data from many hundreds of patients treated with CyberKnife radiation; almost no good data on any form of focal therapy; some rather poor data from the early forms of the Ablaththerm HIFU technology; and near to nothing from the Sonocare technology except from the Ahmed/Emberton group.

    And I have most certainly come across plenty of HIFU patients in America who have reported unsatisfactory results — at least as many as those who are passionately in its favor, like you and Ron. As you well know, most men don’t talk publicly about any of this at all (whether they got good results or bad ones).

  15. Oh … and Jim … Here is something that you definitely have got wrong. Please click here to see Dr. Hashim Ahmed’s brief bio. He may well have been in a fellowship program when he did his first HIFU procedure, but he is a fully qualified specialist in urologic oncology. This means he has to have had at least 7 years of medical training. I think someone is giving you poor information.

  16. Mike,

    After you and I were on CureTalk, I spoke with Dr. Emberton, asking the cost of HIFU in Great Britain and said his “team” charges $21k per treatment. If you are suggesting that Emberton and Ahmed both did the HIFUs themselves, then how can you explain the horrible result? Since their results are far worse than other HIFU studies in Europe, are they two of the worst HIFU physicians on the continent? They truly suck at HIFU and this is probably the reason they are moving to FLA for a new treatment.

    I stand by my comments: (1) Emberton runs the HIFU program and did not do the treatments himself. Ask him. (2) A SonaBlate 500 is a computerized medical device. Why does Yushida have such compelling results and Emberton’s team sucks at it? Again, why? (3) The results of this Emberton study were bad, as we can all see. It is true that Emberton’s team was required by SonaCare to come back to the US for HIFU retraining. Ask him. If this data is correct as you suggest, then I have much less respect for his competence and commitment to excellence. (4) Yes, I am in agreement that it depends who does any treatment, and that applies to radiation, surgery, cryo, FLA, all of it. Which is why I believe your “show me the money” shotgun data is suspect. Studies certainly do not show individual physician data. Why is that? Right now you can go into any public school and find out the individual teacher’s test results and yet for physicians? Yeah right.

    HIFU is just like any other treatment: it is who is doing it. Again, why are we not seeing Dr. Scionti patients complaining like mad on any of the forums? If you have data to the contrary, please share it since you said you have come across “plenty” of HIFU cases that did not go well then it should be easy to find the same thing for Scionti, right?

    Scionti is the most experienced HIFU urologist in the country, has done over 900 and continues to do 15 HIFUs a month. I have personally spoken to three dozens of his post treatment patients and have not heard anyone complain.

    I would not have chosen anyone else to do my HIFU, and yes, I am making your point. 90% of HIFU urologists are not as meticulous or demanding as Scionti, and to your point, certainly not Emberton or Ahmed, to say the least. And yes, I am going to belabor this point: Why are 15 PCa patients spending $25,000 each out of pocket each month to have a treatment done out of the country, to have Dr. Scionti use a SonaCare 500 medical device? Could it be that one or two are happy with the results? And why is it so hard to find patients unhappy with Scionti? For every one of us with prostate cancer, we are charged with finding the best treatment for our situation and then finding the best physician to do said treatment. I wanted a Tesla and not a Ford Focus. I am not a rich man, to be clear, either.

    With 9/12 cores positive T2b, enlarged prostate, I was a very difficult case, and Dr. Kane in La Jolla (UCSD) told me that he could only spare 50% of my nerve bundle doing surgery … which would have meant ED/incontinence.

    I came out of HIFU with Dr. Scionti with no cancer and no side effects. You and I can now watch each other’s progress for the next 20 years to see how we do right?

    Lastly, you and I both believe that active surveillance is the way to go for men who are candidates for it. I could not wait. The number one treatment in the US for prostate cancer seems to be robotic surgery. Am I right? And the results for men across the country who have surgery has been very poor with high numbers of those with side effects. You can find unhappy patients on Yana, US Too, and the NPCI.

    I think it’s time for a major article to come out on RALP results, something that also has a very steep learning curve and a treatment that was grandfathered through FDA approval as an “extension of a pre-existing treatment” … and now US males are getting screwed, pun intended, by being sold a bill of goods, by poorly trained doctors, resulting in horrible side effects that it seems most post-surgery patients experience.

    This has been fun, Mike. I do enjoy the banter and am just as frustrated as you that US males continue to have difficulty finding suitable treatments that do not come with the side effects. I now look forward to your next article on FLA … the newest and greatest solution with no data.

  17. Thank you for these interesting comments. I would like to provide my own feedback to this based on the overall themes in the comments.

    (1) “Side-effects are high from whole-gland HIFU”

    I do not think we are an outlier. These are carefully collected data and reported openly. In other similarly openly reported series there are similar outcomes. Each man who is diagnosed with prostate cancer must ask himself what risk he is willing to accept from the various treatments on offer.

    After surgery or radiotherapy, 15-20% of men have urinary problems and leakage. After surgery or radiotherapy, 30-60% of men have sexual problems and impotence. These data are from the population-based study recently published in NEJM (Resnick et al., NEJM, 2013, also noted on this web site). There are no data to suggest these population-based outcomes are any different now.

    (2) “Complications are high after whole-gland HIFU

    Is this complication rate any higher than what is to be expected after radical surgery or radiotherapy? That is for you to decide. In another population-based study from Canada, from 32,465 patients treated with radiotherapy or surgery, the hospital admission rate within 5 years for a treatment-related complication was 22.2%. The need for a further urological procedure was 32.0%, for a rectal or anal procedure 13.7%, and for an open surgical procedure about 1%. These risks were significantly higher when compared to 32,465 matched controls with no history of prostate cancer.

    I would be careful about putting this down to differences in country. Anyone putting these outcomes down to “inferior care of socialist type medicine” should be careful to note other studies in the US describing similar outcomes (see, for example Lowrance et al. Comparative effectiveness of prostate cancer surgical treatments: a population based analysis of postoperative outcomes. J Urol. 2010 Apr;183(4):1366-72).

    (3) “HIFU has a higher failure rate requiring much more further secondary treatments

    We have known from HIFU and cryotherapy that 1 in 5 to 1 in 3 men on average require a redo HIFU or cryotherapy procedure. Many men value the fact that if there is cancer left in the prostate, the same procedure can be applied. This leads to some additional risk. It is for the man to decide whether comparatively this is better or worse for him when compared to surgery or radiotherapy. It would be important to note that overall 15-30% of men after surgery have some sort of failure in the medium term requiring adjuvant/salvage therapy (hormones or radiotherapy). 20-30% of men after radiotherapy fail and are usually given hormones because the consequences of salvage surgery are tremendous (almost certain incontinence, almost certain impotence, rectal injury requiring colostomy 5-10%).

    4. “My surgeon does all my procedures and gets better outcomes

    All the men in our series were treated by experienced surgeons qualified as proctors for HIFU. We go around many other international centres teaching HIFU on the Sonablate device. Did other junior doctors take part in the procedures? Yes. We have a duty, as do large teaching centres like us in the USA, to train the next generation of doctors. Or would you rather our children’s generation and grandchildren’s generation had no qualified and expert doctors? Did we compromise any man’s care during these procedures? Of course not. Gone are the days where learning curves are accepted. We don’t accept them in the UK. The suggestion that we were summoned to the US for retraining is incorrect. The method of delivering HIFU in the US trials was changed as a result of our feedback.

    5. “HIFU has no future as the results have to be better than existing therapies and discussions about it have been misleading

    The series that we reported is based on whole-gland HIFU. There are some incremental advantages over existing therapies. However, our recent work has centred on focal HIFU. Treating the cancer areas alone and leaving most of the prostate alone. In other words, a lumpectomy. We use cryotherapy as well and are evaluating new ablative modalities. Let me be clear on this. Focal therapy leads to significantly lower side-effects and complications (impotence, 5-10%; incontinence 1-5%). The redo rate is about 1 in 5 to 1 in 4 within 2-3 years. It might be higher with more follow-up

    Each man with cancer will have to ask himself whether he wants the “sledge-hammer” approach on day 1 with its risk of 20% incontinence and 50% impotence and a possible slight benefit in terms of survival or a minimally-invasive approach that limits harm and has encouraging short- to medium-term outcomes of 80-90% success (see Valerio et al. The role of focal therapy in the management of localised prostate cancer: a systematic review. Eur Urol. 2013 Jun 6. pii: S0302-2838(13)00557-5.

    We will be presenting our focal HIFU data on about 500 men in the AUA this year and each man and clinician will need to judge where his equipoise lies on these data.

    Do we have more work to do? Yes, absolutely. Can we deliver a randomised controlled trial of focal therapy versus radical therapy? By past form, the answer is no. Men and their clinicians don’t seem to accept such trials. We are then left with long-term registry series to guide us.

    It is only with groups like ours that do not accept the status quo of harms and limited benefit from the current pathway of diagnosing and treating everything and innovate that we can do our patients justice. For those who want to carry on as they are now, clinicians or patients, this is unacceptable, untenable and unsustainable.

    The individual man with his diagnosis will need to consider the actual data about different treatments and compare it to what data that he and his family are given and make their decision. It is not easy.

    Hashim U. Ahmed, PhD, FRCS(Urol), BM, BCh, BA(Hons)
    MRC Clinician Scientist & Senior Lecturer
    Division of Surgery & Interventional Science
    University College London

    Honorary Consultant Urological Surgeon
    University College London Hospitals NHS Foundation Trust

    Consultant Urological Surgeon
    The Prostate Unit
    The Cromwell Hospital

  18. Dear Dr. Ahmed:

    Thank you very much for your comments. I appreciate your willingness to share your personal perspective. You should be aware that I absolutely agree with you that each patient has to make his own decision about treatment. And the more data that are actually available to patients that they can use to make such decisions the better.

  19. Dr. Ahmed, I agree with Mike and want to thank you so much for sharing your perspective. It is rare to see physicians/stakeholders leave the safety of their professional arena to share current research and understanding with all prostate cancer patients and forums. How refreshing.

    Jim Wickstrom
    PCa survivor and happy post-HIFU patient.

  20. Sitemaster said we should sell our shares in HIFU technology. I wish to refer everyone to fusfoundation.org where a group of committed HIFU enthusiasts are trying to educate and explore the new developments in HIFU. Eight years ago the Swiss treated 9 people with brain tumors. Hours later they all went out to dinner together. Lately the Swiss treated cancerous brain tumors with HIFU; there are thousands of girls with breast cancer being treated all over the world. Why would we sell out holdings, clearly it’s America that stands alone in not recognizing the incredible potential of HIFU.

    I also am a Dr. Scionti admirer, he told me once that HIFU is an art. Some very experienced doctors just cannot read the ultrasound mapping.

    HIFU is the future, if we have a good future on the horizon.

  21. Dear Ron:

    The sitemaster absolutely did not tell anyone that that should either buy or sell shares in anything. He does not indulge in investment guidance. If you read carefully you will see that it was someone else who offered that suggestion. The sitemaster would appreciate it if you looked more carefully at what you think you are reading before making this type of comment!

    And of course HIFU is an art, like every type of invasive treatment I am aware of. The other thing we all know about art is that the quality of art is in the eye of the beholder. Personally, I shall wait to see Dr. Scionti publish some data. It is the normal way for people who claim to have made medical advances to demonstrate the validity of their claims.

  22. My short 2.5-year prostate cancer research journey taught me two things:

    (1) 99.9% of individual doctors do not publish data. Instead published data seem to be produced by countries, universities, and well-funded private companies.

    (2) Few if any published data for prostate cancer show exactly who did the procedure, the number of procedures done in the past, and an individual physician resport card of successes, failures, and side effects. It appears this paper of results conducted by Ahmed/Emberton is no different.

  23. Dear Jim:

    Frankly, if one is going to claim the results that you and Ron claim for Dr. Scionti, then someone needs to report actual data. The fact that most physicians haven’t reported or published good individual data series in the past is no excuse for not doing it in the future. It does, of course, require a significant degree of commitment that most physicians don’t seem to have and that most of their patients don’t seem to understand the need for until it is too late. Don’t you want to be able to see Dr. Scionti’s actual data? At least Dr. Barqawi has just published some data from his focal therapy series (which you told me you would be interested in seeing) … and they don’t seem to be overly impressive either.

  24. For me, Mike, when I was doing my research and inerviewed Dr. Scionti’s patients and could not find any that were unhappy, I rolled the dice. I wanted the least invasive treatment I could find.

    And that is exactly the point Dr. Ahmed made also: “Each man with cancer will have to ask himself if he wants the sledgehammer approach on day 1 with its 20% risk of incontinence and 50% risk of ED. . .”

  25. Dear Jim:

    I am not in any way questioning your individual decision (or Ron’s either). You have every right to make whatever decision you feel like. That is not my point at all. My point is very simply that the supposed leading investigator and “premier implementer” of a new type of therapy has a moral, ethical, and scientific responsibility to publish data supporting the effectiveness and safety of that treatment of her/his patients. Without such data, everything is hearsay, and that is no way to advance medical science. The manufacturer of the relevant equipment has the same obligation (in my opinion).

  26. I don’t think physicians should be able to practice an investigational or experimental treatment like HIFU unless they keep stringent data and publish those data. When physicians (especially those seeing lots of HIFU patients) are not using good judgement by not collecting and publishing data in well-designed studies for a real look at HIFU’s effectiveness it hurts every potential HIFU patient and makes one wonder and question a physician’s true intentions.

    Why the federal government hasn’t forced this issue is another question. Its OK in the USA for medicine to ride by the seat of its pants. That all of Dr Scionti’s patients are happy and well is meaningless without long-term outcome data which would shed more light on the very usefulness and effectiveness of this treatment. Just his unwillingness to do this should be enough writing on the wall. But for others it could be the $15,000 second HIFU treatment

  27. I totally agree with the above comment. Without keeping and collecting and publishing outcome data and using an instrument deemed by the FDA as experimental it’s unethical for HIFU doctors to see hundreds of HIFU patients and not have moral responsibility. Why hasn’t the medical board done anything? Are they invested in keeping the American medical community wallowing in magical thinking? Why hasn’t the federal government set guidelines? And maybe most importantly why are the millions of prostate cancer patients being told in so many words that the data to help and understand the true effectiveness of the HIFU instrument in localized prostate cancer is less important than the $25,000 to $30,000 demanded before a first HIFU procedure.

    Ron Rosen, MD

  28. Dr. Rosen,

    I too agree that research data would help patients understand which treatments are most effective for their situation. But to call out only HIFU and not da Vinci or some types of radiation for a lack of data is suspect. Robotic surgery for prostate cancer seemed to begin in earnest in 2001 and yet we still have incomplete, disaggregated data after a dozen years, a million robotic surgeries and hundreds of thousands of unhappy men whose very manhood has been compromised. And just try and find out the success rates/frequency of side effects from individual physicians. And I have. They speak in generalities and many under-explain the frequency of side effects from their own procedures. Patients certainly don’t get a print out of “stringent data” from their own individual physicians. Why is that? Is it too hard to have a nurse take notes, conduct follow-ups with patients?

    It is the individual physician that is most important in any treatment. For anyone to suggest that “pilot error” in medicine is less frequent than other professions should not be practicing. Mistakes happen all the time.

    Have you had prostate cancer? There is quite a bit of emotion going on in one’s mind for prostate cancer patients and the families. And those who want to put the odds in their favor have to do considerable research to find the most competent, high-volume surgeon in their area, if that is their choice. Most, however, are thrown into a whole new world of complicated treatments, difficulty in understanding the lexicon and gravity of the different treatments, and physicians who are not all above board when discussing their own professional competence and efficacy of treatment.

    That is true for HIFU, FLA, da Vinci, radiation, all of it.

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