Approval criteria for SonaCare Medical’s HIFU technology


The U.S. Food & Drug Administration has now posted, on its web site, the approval letter issued to SonaCare Medical with reference to the approval to market the company’s Sonablate® 450 technology.

According to the full text of this letter, the Sonablate 450 technology has been indicated for “transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue” as a generic “class II” high intensity ultrasound system for prostate tissue ablation that

transmits high intensity therapeutic ultrasound (HITU) energy into the prostate to thermally ablate a defined, targeted volume of tissue, performed under imaging guidance. This classification does not include devices that are intended for the treatment of any specific prostate disease and does not include devices that are intended to ablate non-prostatic tissues/organs.

The technicalities of how specific medical devices can get approved are complex, but what seems to have actually happened is that Sonacare Medical found a way to submit a different type of application to the FDA (in March this year) allowing for this type of approval. This type of approval did not require SonaCare Medical to prove either effectiveness or safety for their form of HIFU.

The approval of HIFU under this type of legal pathway will raise all sorts of questions about the actual use of HIFU in the treatment of prostate cancer, and we have listed some of these below:

  • It would appear likely that the Ablatherm technology from EDAP-TMS can also gain  approval under exactly the same criteria.
  • Because of the lack of necessity for data on the safety and effectiveness of any form of HIFU in the treatment of any form of prostate disorder (prostate cancer included) under this approval pathway, insurance providers will have a great deal of leaway in deciding whether they will or will not cover the costs of particular types of HIFU treatment in particular patients. We will have to wait and see what happens, but if there are more good, unpublished data available on the effectiveness and safety of HIFU in specific categories of patient, then it would be in everyone’s interests to see these data published as fast as possible.
  • Hypothetically, there appear to be no restrictions whatsoever on how this form of HIFU could be used so long as it is used to ablate prostate tissue. The range of opportunities appears to encompass:
    • Focal therapy of one or two small organ-confined tumors with the prostate
    • Treatment of the entire prostate gland and the seminal vesicles
    • Treatment of radio-recurrent prostate cancer
    • Second-line treatment of recurrent prostate cancer post-surgery
    • Treatment of specific metastatic sites of prostate cancer
  • Individual prostate cancer patients who wish to pay for use of HIFU in any of the potential uses listed above themselves (if it is not covered by their insurance provider) can, presumably, do so if they want to (and if they can find a HIFU provider with the experience to treat them), and it will be legal to do that here in America

The real questions that need to be answered are therefore still going to revolve around the effectiveness and safety of high-quality HIFU in any or all of these specific and different uses. A key question will be what CMS decides it is willing to cover for Medicare patients.

Two other unanswered questions at this time now appear to be:

  • Did SonaCare Medical get some legal/regulatory advice that helped them to circumvent the regulatory approval pathway originally requested by the FDA or did the FDA itself actually help SonaCare Medical to submit the different form of application for regulatory approval?
  • Can SonaCare Medical now gain approval for its Sonablate 500 technology here in the USA through the standard 401(k) appliciation process now that the Sonablate 450 technology has been approved.

We understand that these regulatory issues are of limited interest to most patients and their families who are simply pleased to see a whole new type of treatment for prostate cancer available here in America. However, the regulatory approval issues may have major implications for the regulatory evaluation and approval of other forms of technology in the future.

40 Responses

  1. Mike,

    Another fabulous explanation of new medical technology. It is so difficult for Joe Public to understand everything from medical abstracts to technology choices and then disaggregate how each has relevance to us individually.

  2. This is a bunch of garbage!!! Approval to treat what disease with what outcomes? I find it very, very disappointing and will be contacting the FDA as soon as possible for clarification.

  3. Dear Dr. Chodak:

    I have very little doubt that the FDA did a great deal of internal soul-searching and took a great deal of external advice before issuing this approval. I doubt if you are going to get much more information (on the record) than the statements in the approval letter.

    If you look at the approval information issued for Accuray’s CyberKnife radiation technology, it is even less specific, stating that this technology is “indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.”

  4. And that is why we spend ridiculous amounts of health care dollars without really knowing if men are benefiting and the dollars are well spent. Is it really unreasonable to delay approval until benefit is proven?

  5. Dear Gerry:

    That’s a whole different question. … The FDA interprets the law as best it can. Congress writes the law. The one thing that I am quite sure about is that within your and my remaining lifetimes we are going to have to find ways to significantly cut what America spends on healthcare each year or at least make sure we are getting much better value for the money!

  6. Dr. Chodak,

    I don’t think this is too hard to figure out since urology and prostate cancer was your business for decades.

    For me, with Gleason 6, T2b, 9/12 cores positive, and growing, I was told that surgeons would probably not be able to spare my nerve bundle, resulting in probability of incontinence/impotence. Radiation, as you know, has it’s own issues too.

    So I chose HIFU with Dr. Scionti and now have no cancer and no side effects.

    How many prostate cancer patients in the US would love to have the same outcome?

  7. Very interestiing. This is beyond arcane, at least for the patient.

    Why, in your opinion, is HIFU permitted to be used on seminal vesicles? Are they part of the prostate? If so, is it also OK to use HIFU on lymph nodes and other tissue near the prostate?

  8. I suspect that many of us had hoped there would be some encouraging success and safety data supporting this approval. Unfortunately, there is none. I am impressed with the report of the Uchida group, with their special version of Sonablate 500 and associated technology (the “SB500 tissue change monitor group”), but, outside of that specific group involving the Uchida team, are there any papers that document success with HIFU that is anywhere near the success achieved by surgery and radiation? HIFU appears to work very well in patients who likely need no therapy at all, such as those well qualified for active surveillance (not “elucidated 1”), which is not much of a claim to fame, and in those patients who have only been followed-up for 1, 2, or maybe t3 years, with high rates of failure in subsequent years, which is also not much of a claim to fame. Somehow I’m not real impressed with the “advantage” that you can do HIFU again if it fails the first time.

    Question for elucidated 1: I just checked PubMed and saw that Dr. Scionti has not published results in a peer-reviewed journal. Do you know if and where he has published his own results informally? At his website Dr. Scionti provides a misleading interpretation of the Uchida results noted above, including leading the reader to believe that the one impressive form of treatment applies to the whole large population and also including the fact that there is no emphasis by Dr. Scionti on the great difference in results between that one impressive form and previous forms of HIFU technology used by the Uchida team, results for which were far from impressive. While I am skeptical, I hope Dr. Scionti has also hit on a successful form of HIFU, and I hope he will be able to prove that many of us have been undeservedly pessimistic.

  9. The seminal vesicles are normally considered to be an integral component of the prostate. They are removed along with the prostate at surgery and they would normally be radiated along with the prostate if one had radiation therapy.

    The reason I state that, hypothetically, under this approval, one could use HIFU to treat positive lymph nodes is that the approval is for “prostate tissue ablation”. Prostate cancer tissue in positive lymph nodes is prostate tissue that has migrated (metastasized) from the proste to the lymph nodes. Since it is prostate tissue, it falls within the remit of this approval.

    Please appreciate that I am not saying that anyone should necessarily use HIFU in this manner. I am only saying that at least hypothetically it would appear to fall within the indication approved by the FDA. The point I am trying to make is that the extent of this indication appears to exceed anything for which there are data to substantiate the clinical use of HIFU.

  10. Jim,

    When I did my prostate cancer research, I vetted physicians/radiation specialists and HIFU doctors as well as prostate cancer patients. But after interviewing two dozen HIFU patients, I could find no one who was unhappy with their results from Dr. Scionti. Considering that he will now be doing HIFUs from his Sarasota office, it will be interesting to see how many treatments he does in 2016.

    Arguably, Dr. Scionti is one of the most experienced HIFU physicians in the US. That might be important compared to the “pilot error” that continues to dog the da Vinci treatment in the US.

    More compelling is the lack of hard copy data provided by da Vinci surgeons that include frequency of salvage from treatment as well as frequency of side effects.

  11. Dear Jim and elucidated1:

    (1) I will make you an absolute guarantee that if we start to see a really major uptick in the numbers of physicians who start to use HIFU to treat prostate cancer here in the USA, we will start to also see a major uptick in the level of “pilot error” related to the use of such treatment. It is well understood that, like any other new technology, it takes time to use HIFU well and some specialists are much better than this than others (as is demonstrably true for surgery, radiation therapy, cryotherapy, etc., etc.).

    (2) Over the past couple of decades the level of risk for significant side effects associated with surgery has actually been falling (whether the surgery is done as open surgery or using da Vinci robotic equipment). There are several basic reasons for this: (a) There has been a decline (small, but existent) in the numbers of radical prostatectomies being carried out as urologists have started to accept the idea that most low-risk prostate cancers can just be monitored. (b) There has been an increasing tendency for surgery to be carried out by a smaller number of urologists and urologic oncologists who specialize in the conduct of radical prostatectomies as opposed to the situation in the late 1990s when the vast majority of urologists would carry out a few such procedures every year … and many of them either didn’t have the skill level and/or weren’t doing enough procedures to do the operation really well. However, this problem hasn’t been eliminated entirely. (c) There are at least some data that suggest that the use of robot-assisted surgery is associated with lower risk for both incontinence and erectile dysfunction post-surgery. I am not sure that I believe those data because my suspicion is that it has much more to do with the skill levels of the surgeons using the equipment.

    My point is only that the quality of patient outcomes from the use of any invasive procedure carried out by surgeons (and interventional radiotherapists too) is generally far more dependent on the skill of the operator than it is on the technology itself — if the technology really does what it is claimed to be able to do. An inherent problem with HIFU is that we don’t have the long-term data to show that it offers 10-year (or even 5-year) outcomes close to those demonstrated by large series of surgery, external beam radiation therapy, and even brachytherapy patients. And still less do we know the long-term outcomes of (say) the first 100 patients treated by inexperienced new users of this technology.

  12. Re: Vetting Dr. Scionti …

    Hi Glenda1987: Did you happen to tabulate how long it had been since each of the patients you interviewed had their HIFU treatment? Did you have any or do you know how many patients were still happy after 5 years since treatment by Dr. Scionti? Did you happen to record how many patients had an active surveillance eligible case versus how many had more aggressive low-risk, intermediate-risk, and high-risk cancers, and also which of those patients had at least 5 years of post-HIFU experience?

  13. Re “Pilot Error”, but also Technology

    It’s hard to see how an expansion of HIFU would not suffer from “pilot error” or “learning curve” issues.

    However, there is also concern that key equipment technology — HIFU itself, imaging/targeting, patient support during procedure — may be critical. The Uchida team that has posted the impressive results seems highly experienced, yet their earlier efforts, even with a less advanced form of Sonablate 500, were not successful. From reading their 2014/2015 paper noted above, a set of advances seems to be involved in their success. This has been described in a commentary on this web site from August 2014 and the related comments.

  14. Jim,

    I interviewed over two dozens HIFU patients from Suaraz, Pugash, Scionti, Lozar, etc. with treatments from 2006 to 2012. Since my treatment, another two dozen. Interestingly, Dr. Pugash had Scionti do his own brother (!) and said he’ll also have Scionti do him when it’s time!

    As Mike will tell you, we both agree on choosing the most experienced physician no matter which treatment is chosen, then go from there. Arguably, Scionti fits that category for HIFU. In fact, I’ve heard rumors that he’ll be running a HIFU training center for Sonablate in Florida, too.

    One reason I personally chose Dr. Scionti is that he is known to to be obsessive/compulsive about getting it right every time. And apparently he does since he’s had men waiting in line to get HIFU done.

    As you know, HIFU is best for low- and medium-risk prostate cancer patients. And even then, it’s dependent on tumor location/size, aggressiveness, etc. Anyone considering HIFU, or any other treatment for that matter, should first do a mpMRI to increase chances of success.

    What I find amazing is that many of the HIFU haters out there, and there are a ton of them, have one thing in common: not one has ever witnessed or performed a HIFU and yet they complain incessantly about the procedure, blindly. And that would include Dr. Chodak.

    Lastly, I would like to see Mike’s data that the side effects from da Vinci/open surgery has “been falling for the the past two decades.”

  15. Dear Elucidated1:

    I would also like to see some really compelling data about what I suspect has been a small decline in the rate of side effects and complications associated with surgery as a treatment for prostate cancer over the past 20 years. I know of no paper that has offered a really compelling assessment. My comment is based on indications from a commentaries in and on a whole range of papers over that time, period but it is impossible to provide any sort of accurate assessment of reality because, in the end, it all depends on the skill and experience of each individual surgeon and the precise types of patient they operate on. (For example, the best surgeons at Memorial Sloan-Kettering started to focus their skills on higher-risk patients several years ago. This would certainly have increased the levels of erectile dysfunction among patients in their surgical series.) In other words, it only matters from a societal point of view whether the overall rates of specific complications have been falling, and I don’t think anyone could find the relevant data to “prove” that — one way or another.

    What I do know is that the best surgeons have, over the past 20 years, been able to show improvements in their individual risk for side effects and complications. This editorial by Marberger from 2011 summarizes many of the problems in trying to make accurate comparisons about such issues. With no large, high-quality, long-term registry data that accumulate detailed and pre-specified outcomes and complications over time, we have no way of being able to really build the database we need to make accurate comparisons between the various types of treatment available … and this is true for every type of first-line treatment for prostate cancer.

    Let me be very clear that I am not in any way trying to suggest there has been any sort of massive decrease in the risk of incontinence or erectile dysfunction over the past 20 years. However, there has been a massive decrease in risk for blood transfusions during surgery — as a consequence of better surgical technique overall and, specifically, the use of laparoscopic techniques (robot assisted and non-robot assisted) to carry out the surgery. In the late 1990s most radical prostatectomy patients were still being asked to bank blood prior to their surgeries in case a transfusion was needed. Blood banking prior to most radical prostatectomies today is very rare.

  16. Hi again elucidated 1,

    You mentioned the “HIFU haters”, and I have no issue with your belief that there are people who irrationally reject HIFU and are passionate with that rejection, for whatever reason. However, many of us, me included, actually have hoped for a long time that HIFU would prove successful. The problem is that the published evidence has been clear that it has not been substantially successful, even in low-risk men, with the striking and encouraging exception of that report from the Uchida team that is cited above. (By the way, I was the one who encouraged Sitemaster to report that paper.)

    As you may know, there are HIFU series that have been published from quite a few places across the globe. With the one exception above, the results have been uniformly dismal compared to results for similar patients with other therapies. I can provide detail if you wish. Despite this lack of success, these reports consistently express the sentiment that the safety and effectiveness of HIFU has been supported by the study. Arguably that is so for the safety side, but it is demonstrably untrue for the effectiveness side. Indeed, some of the studies of low-risk patients show results comparable for active surveillance patients, where over half seem to never need treatment; this suggests that HIFU in these studies had minimal if any favorable effect on the disease!

    Now that we have the impressive 2014/2015 Uchida paper, assuming that the team’s results can be replicated elsewhere, it seems clear that HIFU success is dependent on the particular set of technologies applied, including know-how. As for doctors around the world who perform many HIFU procedures, we have no good basis to know whether they have moved beyond previous failure and indeed have mastered an approach that is truly effective and safe. Dr. Scionti may have found a way to make HIFU effective, but we have no reliable way of knowing that; on the other hand, he may be extremely diligent in implementing a specific form of treatment that has one or more major flaws. Does it bother you that he has not published his results, despite advocating an investigational therapy where all results except one up to this time have been discouraging? Many of us have seen abundant instances of doctors who enthusiastically and confidently advocate approaches that later turn out to fall far short of their claims. It bothers me that Dr. Scionti’s website leans on a skewed version of the Uchida results without statements and evidence that he is using the same (or better) technology.

    What is critical is that evidence extend at least as far as 5-year follow-up for the low- and intermediate-risk patients where it seems HIFU has a potential role (not addressing salvage here). In a number of published HIFU series, the treatment appears fine for the first 2 years and sometimes the third, looks iffy during the fourth, and looks poor with results of 5 or more years of median follow-up. With low-risk patients, in view of the fact that roughly 50% to 60% of them would be fine even with no treatment at all but just active surveillance, we need to see excellent non-recurrence rates, preferably in the upper 90% based on patients followed for at least 5 years.

  17. Re: evidence for “small decline in the rate of side effects and complications associated with surgery”

    Hi Sitemaster and elucidated1,

    Regarding ED at Memorial Sloan-Kettering Cancer Center (MSKCC), a decline following surgery apparently does not depend on the surgery alone but rather on countermeasures for this side effect as well. MSKCC surgeons are able to refer their patients to Dr. John Mulhall, MD, an expert in sexual health at MSKCC. He published a book entitled Saving Your Sex Life: A Guide for Men with Prostate Cancer in 2008, and I believe he has an updated version in the works. One of the main messages is the importance of early rehabilitation of the penis; he has researched the effectiveness of the well-known drugs in doing this.

  18. Here is the number one thing I find compelling:

    On every prostate cancer website, from Medscape to the blogs like this one, everyone has their opinion of treatments, and data from “Should PSA testing be optional (Medscape ad nauseum) to “Focal Laser Ablation” is the best treatment out there. Everyone seems to be an expert.

    And it’s real easy for urologists/physicians to have their personal biases, some financially based, but when it is you that has been diagnosed with prostate cancer, all of the rules seem to change.

    Suddenly one is thrust into a medical arena where the physicians do not even agree with each other on treatment; where the learning curve for Joe Public is very steep; and unless they have an unbiased, competent urologist guiding them through the choices with the results that may not be the best for the patient.

    But it angers many men to see they’ve been led down a path of incontinence/impotence and were not properly counseled on the gravity should things go south. One man I interviewed in 2012 was very succinct about how he felt about being told da Vinci surgery was his best choice. He was not only uninformed, only to find out after fact that his physician screwed up and that he would be spending $400 a year for Depends, and never see another erection.

    He told me: “I just want to meet my doctor in the parking lot and beat the shit out of him.” And that is exacty what he told me.

  19. Dear Elucidated1:

    First … There is nothing different in all of this about prostate cancer. It is the way the entire American healthcare system works because it benefits the system to confuse everyone and because one of the “rights” not included in either the Constitution or the Bill of Rights — but enshrined by generations of behavior — is the right to believe that our individual opinion is correct … even when we know nothing at all about the subject matter.

    Second … While I realize that I do have rather more knowledge about the way health systems work and the management of certain disorders that is not commonly granted to Joe Public, I have come to learn that Joe Public doesn’t often do his homework at all. He thinks that if he reads something on one blog site or web site or in one brochure, it must be truth that applies to him … which (as you have noted) it often isn’t. I tell patients all the time that there is an obligation on them to make damn sure they know what they are doing when they are told they have an illness, but many Joe Publics of my acquaintance have spent way more time agonizing over what car to buy than they ever spend thinking about what doctor(s) to see about a specific condition or how they want to have that condition managed.

    Third, as a consequence of the two prior items, lots of Joe Publics end up getting badly treated, the wrong way for a condition that may not even have needed treatment at all (prostate cancer specifically included!). Some of them then want to blame everyone else (and sometimes they are entitled to blame at least one other person, but not always).

    Now you are of course as entitled as you want to be to get angry about all of this. My personal view, however, is that this is one of the two most critical signals of just how appalling our educational system is (the other being our complete lack of individual financial knowledge). It’s high time our education system rethought what it is people need to know to be able to survive well in an increasingly complex world.

    Come to think of it, it may be the failure of our educational system to address personal health care and financial management that is the singular cause of the evident outcome — that healthcare bills are, by far, the primary reason for personal bankruptcies in America every single year.

    If you think this is bad for prostate cancer, try getting a really rare disorder that takes 7 to 10 years before it can be accurately diagnosed by one of the two or three physicians in America who really recognizes it when s/he sees it … but then has to tell you that there is no known treatment because it is too obscure for anyone except him/her and a couple of other folks to ever have actually worried about it!

    :O)

  20. Thanks, Mike. I agree with much of what you said. But what you know about the medical field, I know about education, so when you said “just how appalling our education system is “… it sounds kind of naive.

    I guess you haven’t looked much into Common Core or been in classrooms in some time. If you check out Blooms Taxonomy of learning, using synthesis, evaluation, analysis, all higher level thinking skills, that is what Common Core is built around.

    You and I “learned” through simple memorization and comprehension and I’ll bet you were good at both. Isn’t it amazing that we still have kids graduating and going to Stanford, Harvard and MIT?

    In fact, if you feel like we can blame our education system for the ills of Joe Public, you might as well throw in more things to go with it.

    What I feel is important is professional accountability and oversight for physicians that are ineffective communicators, biased self-referring physicians and an enabling medical field.

    Today I spoke with a man from Seattle doing “his” due dilligence and he said when he met with his urologist to go over his prostate cancer diagnosis, the physician said ‘we have an opening on Friday for surgery.” Wow.

  21. Dear Elucidated1:

    (1) At least half of America (and arguably a good deal more than half) is trying to rip down the Common Core (or hadn’t you noticed?).

    (2) I was never taught through a process of memorization and comprehension. I was taught to think, to ask tough questions, and to know how to seek answers to those questions. … But then I went to private schools in England in the 1950s and the 1960s.

    (3) I don’t disagree with you that the medical profession has utterly failed to manage the biases of its members with any degree of competence … but that’s because of our own stupidity as a society in endorsing the unjustified “right” that I mentioned previously — the right to be right based on opinion alone.

  22. Mike,

    You said: “At least half of America is trying to rip down Common Core.” Wow, Mike, you have exposed yourself a little too much here!

    But I have been involved with Common Core nationally and locally. I have been in the classrooms watching CC at work. I follow Common Core on twitter and the blogs on both sides and here is what IS true.

    1. Those Americans who are against Common Core do not know jack about it. They have not read the CC standards, do not understand Blooms Taxonomy, and have NOT seen Blooms Taxonomy used in classrooms. That IS a fact. Ironically, ignorance is bliss here.

    2. The majority of those against Common Core are not college educated, have difficult times helping their children with assignments and want to go back to memorization/comprehension to take tests. They do not want their children to use citations for positions and research, that YOU, find important. But Common Core DOES demand students explain their answers and use citations.

    Mike, I have shared before how important your research, and explanations of abstracts is to many of us who have been down the challenging prostate cancer road. So, since you like due diligence from prostate cancer patients, it might help you, too, to look into Common Core starting with this.

  23. Dear Elucidated1:

    You APPEAR to be assuming that I am part of the group that wants to rip down the Common Core. I never suggested that. You do seem to make these types of assumptions very easily. Why not check before you assume?

    I see the Common Core as a BEGINNING toward decent educational reform.

  24. At least we can agree on your last line. I do enjoy this banter.

  25. OK … but just bear in mind that one of the core tenets of what I consider to be a sign of a decent education is “Never assume. Validate and verify if at all possible”.

    :O)

  26. Mike, you have made your opinion on public schools very clear. And amazingly, without personal “validation and verification!”

  27. Do we get to discuss the Benghazi hearings next? =-)

  28. No.

  29. What do you mean by a “public school”? I have no particular opinion about any specific type of school today … here in America or anywhere else.

    I have opinions about quality of educational outcome because I have decades of experience in hiring (sorry, that should state “reviewing resumes of, interviewing, and occasionally hiring”) the consequences. That’s a very different animal.

  30. Apparently the folks at Medscape have no more insight than I do into exactly what went on behind the scenes to allow the approval of the Sonablate 450 device for “prostate tissue ablation”.

  31. Dear Jim:

    Interestingly, a new paper by O’Neill et al. just published on line in the Journal of Urology, and based on prospectively collected data from two large cohort studies, appears to confirm my earlier assertion that the side effects associated with robot-assisted surgery have been falling over time and are now superior to those of open surgery.

  32. I don’t think many physicians even do open surgery anymore, do they? The only one near me is 70 years old who didn’t make the jump to robotic. Do you know what percentage of open surgery is done?

    I’ve been to prostate cancer groups and the two treatments patients complained about the most were surgery and radiation, of which both dominate the US market. In 5 years will HIFU and FLA make a dent in the US?

  33. Re widening margin of side effect superiority favoring robotic-assisted versus open surgery

    Dear Sitemaster (your 10/26/2015 at 3:02 pm) and Jim:

    I’m wondering how much of the superiority in the O’Neill study is due to the facts that the patients getting robotic surgery had to have been overwhelmingly in the CEASAR study, done much later in time (enrollment 2011 to 2012) while the PCOS study almost surely overwhelmingly involved open surgery patients with very few robotic patients and was enrolling far earlier (1994-1995). The latter time frame was not that long after the first nerve sparing surgery in 1982, and it was shortly after the surge in diagnoses in the late 1980s and early 1990s due to screening. Only a few years earlier than 1994-1995 a hefty proportion of men would have been diagnosed with disease beyond the reach of surgery, so better surgery would not have been around for more than a few years at many centers. Therefore, in view of the long learning curve for open surgery, it may be that many side effects in the PCOS patients were due to immature open surgery techniques practiced by many surgeons. It strikes me that comparing these two very different eras is tricky. I’m curious whether the authors of the O’Neill study addressed this issue as a possible or likely confounder for their results.

  34. Dear Jim:

    (1) I think something like 80% of all surgeries are now done using da Vinci equipment, but there is a still a small, highly skilled group of older specialists who still do open surgeries.

    (2) Since radiotherapy and surgery do indeed still dominate the market (as they do in most of the world) it is hardly surprising that — among the patients who are complaining — these are the two forms of treatment most complained about.

    (3) I think the ability of FLA and HIFU to make a signifciant dent in the US market within 5 years will be highly dependent on the quality of the outcome data that is available … as yet there isn’t any significant outcome data fro either form of therapy in this country!

  35. I have now been observing/participating in the prostate cancer arena for nearly 5 years. The only people obsessed about “outcome data” on a grand scale are those that are in that business, as we see on this site, Medscape, etc.

    But when it is you that has prostate cancer and you want to have two goals, to get rid of the cancer, and yet not have the side effects, all of the rules of “data” seem to go away. Then the search becomes finding the right physician to do the right treatment. We can see that every single day on “Us Too.”

  36. Dear Jim:

    You are muddling up two very different things … The need to know whether any type of treatment works well in certain types of patient (with an appropriate level of safety) and then who you want to have carry out the type of treatment you want to have. Neither exists in a vacuum. I know of no treatment that only one or two physicians can do well that no one else can do (either well or badly).

    You are by no means the first person to miss the importance of this distinction as a part of the learning and decision-making process.

  37. Mike,

    It’s time for you to tell everyone what treatment you would choose, if you had a Gleason score of 7, T2b, but only three cores positive. My point stands: When it is you that is diagnosed, pragmatism is compromised by family and emotion, as well as the difficulty of choice decisions.

  38. Dear Jim:

    But I can’t. Your point is entirely correct. Without the emotional issues, anything I told you would be subject to the possibility of change if I actually was diagnosed. The decision is not an abstract one. I can, on the other hand, tell you that any decision that I might make would be subject to the precise quantity and position of the three positive cores, whether the Gleason scores were 3 + 4 = 7 or 4 + 3 = 7, and the results of a multiparametric MRI if I hadn’t already had one as part of the biopsy process. I might, for example, still be a good candidate for hemiablation as opposed to whole gland treatment.

    As we all know, there are no compelling data to argue in favor of any one of the several possible whole gland options if I actually needed treatment. As I have stated before, however, with low- or favorable intermediate-risk disease, I would quite certainly elect active surveillance because in that case the data are extremely compelling and there is always the chance to change one’s mind.

    The other thing that I can tell you is that the number of physicians who I would consider letting near me with a scalpel or any form of radiation therapy is extremely small. The number I would let near me with any other type of treatment is even smaller!

  39. I’ll give you the Straddling the Fence Award, which you are quite good at!

    But if you remember the story of Terry Herbert, who created YanaNow, a great web site for prostate cancer patients, your response is almost identical to his, and now Terry is dead … from prostate cancer.

    He just waited too long. I guess he just did not have enough cogent data!

  40. Dear Jim:

    I shall accept the Straddling the Fence Award with honor. Thank you. However, …

    My answer is actually very different to Terry’s. Terry never had any form of standard first-line therapy when it might have benefited him. He simply practiced watchful waiting from his late 40s until it was clear that he needed androgen deprivation therapy, by which time he was doomed to metastatic prostate cancer in his mid 60s. He would still argue today that this gave him something like 15 years of high-quality life unencumbered by the side effects of first-line therapy (choices for which were pretty limited back when Terry was diagnosed in South Africa).

    If I was diagnosed with Gleason 4 + 3 = 7 disease, clinical stage T2b, with a PSA of under 10 ng/ml, tomorrow, I would get first-line treatment (after doing some further detailed research). But I am still not in a position to tell you exactly what! It would depend on the details.

    :O)

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