The value of focal therapy in the treatment of localized prostate cancer


The appropriate use of focal therapy in the treatment of low-risk and perhaps intermediate-risk prostate cancer is a very controversial topic (despite the heavy promotion of this type of treatment by a relatively small number of clinicians).

In a new article in the Journal of Clinical Oncology, Giannarini et al. have laid out the arguments for why the value of focal therapy is unproven to date. The full text of this article is available on line and is important reading for any prostate cancer advocate or support group leader (whether you agree with the authors or not).

The authors’ basic premise is that we have very limited data to support the premise that focal therapy is clinically effective by comparison with simpler (and less invasive) expectant management for low-risk disease. We certainly have insufficient data to support the idea that focal therapy is effective in the management of intermediate-risk disease.

It is absolutely the case that there is a huge range of unanswered questions about the efficacy, safety, and long-term benefit (or lack of benefit) of focal therapy for localized prostate cancer — regardless of the type of focal therapy used (e.g., cryotherapy, laser ablation, high-intensity focused ultasound [HIFU], and others). Never one to hide his opinions under a bushel, Dr. Gerald Chodak has already commented on this issue on his blog site on Medscape, where he states that:

The only way we will ever know whether this therapy has merit is to conduct a randomized trial. Case series simply do not allow us to evaluate the safety and efficacy of focal treatment because many patients may have a cancer that simply is not life-threatening. To use focal therapy and report that patients did well in the long term is really not evidence that this is a justifiable treatment.

In my opinion, only IRB-approved protocols should be used to treat patients. Men certainly should not be charged for this experimental therapy, and really, without a randomized trial, we will never know whether focal therapy works in the long term.

We have considerable sympathy with the perspective of Giannarini et al. and Chodak: without well structured clinical trials, we are never going to know whether focal therapy is any better than expectant management for men with low-risk disease — even though the idea of less invasive treatment may sound good to the layman. It is time for the leadership in the urology community (and the radiation therapy community) to make a stand and start to insist on proper clinical trials of new types of surgical, radiotherapeutic, and other treatments for localized prostate cancer. Just because this didn’t happen in the past is no excuse for it not happening now.

At the other end of the scale, there are always going to be those patients who will willingly pay to have types of treatment that are unproven because they think that such treatments may be more beneficial than the standard of care. Such patients are most certainly entitled to make such decisions, but it is hard to see why insurance companies or Medicare should be covering the costs of focal therapy here in the USA without much better data to support the value. And if appropriate clinical trials were put in place (even if it was just a high quality registry trial with a centralized pathology system) then that would offer another mechanism to generate the data we need to be able to place a value on focal therapy compared to other forms of management in highly-defined sets of patients.

55 Responses

  1. I find it humorous that anyone in or out of the urology/radiology community would suggest/subscribe to “clinical trials on surgery/radiotherapy/other treatments.” Are you kidding?

    There is absolutely no benefit to the professional stakeholders in the prostate cancer industry to do that. The only ones who would benefit would be the prostate cancer patients who are close to being “lambs” in the world of prostate cancer. With a constant yearly stream of 240,000 prostate cancer patients entering the world of a billion dollar industry, enabled by health insurance companies willing to pay for surgery/radiation, etc., why would any of those entities self-regulate/comply to oversight when it is not in their best financial interest?

    As a prostate cancer survivor, I have read dozens of Dr. Chodak’s “expert opinions.” He appears to be a retired, old school urologist who is not current, has obviously never witnessed HIFU, FLA, or any other less invasive treatment and yet he calls for clinical trials for only them?

    When Da Vinci robotics was “grandfathered in as an extention of a pre-existing treatment in 2001” there were hundreds of thousands of poor results due to pilot error, which anyone can read about on the blogs/forums. And yet to this day, men are being told that is the best treatment to “get rid of the cancer.” And there are thousands of prostate cancer surgeons who over-prescribe the surgery and under-explain the permanent side effects.

    If this forum, Dr. Chodak or any of the thousands of urologists want to really want to make an ethical statement, then it is time to collect hundreds/thousands of urologists/radiologists to create one demanding voice in the political world of medicine vs. profit. Can this forum and Dr. Chodak put together a consortium of medical thinkers/physicians to create a dialogue on the issue? Can you find 100 physicians who agree with “clinical trials” on a treatments?

    Or can Dr. Chodak and this forum find just 10 physicians who join the dialogue on this topic so patients and professional stakeholders can organize and mobilize to create change?

  2. Dear Jim:

    As I said before, just because things have been done one way for 30 years doesn’t mean they should go on being done that way. I would point out to you that you seem to have a personal split in your opinion about all this because you think the HIFU should have been approved to treat prostate cancer — and (to my joy at at least) the FDA insisted on clinical trials!

    You can say what you like about Dr. Chodak, but I have known him personally for 35 years now. He is opinionated, difficult at times, hilarious at others, and consistently asks questions that others do not ask. But one thing I know about him more than anything else is that he has advocated for high quality patient care for all of those 35 years, and he was one of the very first people to ever publish an academic article on the over-treatment of prostate cancer.

    If I had the time to do it, I don’t think I would have the slightest trouble finding 100 urologists and/or radiation oncologists (not radiologists; they just look at pictures) who wanted to see good trials done of new forms of therapy. However, I still have a full time job as well as doing what I do. How about you doing it?

  3. Mike, thanks for your response.

    (1) I have never seen Dr. Chodak call out the urology/radiology community on Medscape or anywhere else on the topics we are discussing. But I have seen countless missives by him denouncing focal therapy and demanding clinical trials before he finds value for it. He can’t have this both ways and just cherry pick which ones he is comfortable with calling out.

    I stand by my comments. Just because someone is a certified urologist does not give one credibility in all arenas. Dr. Chodak has never witnessed FLA or HIFU but now he has strong opinions on its credibility?

    (2) Prostate cancer patients are desperate to have discourse with urologists/radiologists on the forums. But they are nowhere to be found. They seem comfortable with their own metaphor … waiting for patients to make appointments to discuss their issues. And even then, many do not allow e-mail/cell phone communications from patients. It truly compromises the ability for patients to communicate when they have questions/concerns.

    The only professional I have seen actively communicate on the forums is Dr. Walser in Texas on UsTOO. He is impressive.

    And yet right here on The “New” Prostate Cancer Infolink, we do not seem to be able to find any physicians who will join in the discussion.

    Can we find just one who is current who will answer questions and about the different treatments and possible solutions or will that glass ceiling continue to become more translucent?

  4. If the establishment had good treatments that stopped the cancer and had minimal side effects, I would agree with you. But radiation and surgery often fail as cancer treatment and usually have significant side effects.

    The focal therapies definitely have less side effects, and may work just as well or better for cancer control. And they still leave open radiation, cryo, and sometimes surgery. Radiation leaves few backup options and surgery may well spread a well contained cancer.

  5. Dear Doug:

    (1) No one is suggesting that current therapies are adequate. They aren’t. But at the other end of the scale, no one has shown us any data to actually suggest that any form of focal therapy can produce similar efficacy levels with fewer side effects in men who actually need to be treated. If you have seen such data, please share. I haven’t.

    (2) Without proper trials, all we are going to get is a repeat of the “radiation vs. surgery wars” of the 1970s and 1980s. This will be of no value to patients because everything gets based on personal opinion (of the type you are expressing) as opposed to actual data.

  6. Dear Jim:

    Here are some of the reasons that even most of the nicest and well-meaning urologists aren’t willing or able to participate in the forums:

    (1) When they say what they think, many so-called “advocates” are simply rude to them. If you’d spent years learning to become even a half-decent specialist at something, how would you feel if someone with no medical degree or real medical experience started to be rude to you about the subject you had specialized in?

    (2) Most urologists are only able to provide really sophisticated answers about one or perhaps two different types of treatment — the ones they specialize in. Outside those topics, they have nothing very helpful to tell you. For example, I don’t expect Dr. Scionti to be able to speak knowledgeably about the latest techniques to optimize a nerve-sparing prostatectomy, and I don’t expect Peter Scardino to be able to discuss the details of how to do HIFU. So the answer to your question “Can we find just one who is current who will answer questions and about the different treatments and possible solutions?” is actually “No, we can’t” — because we’d need several. And on top of that, the specialists in the various types of treatment don’t even agree with each other.

    (3) It’s very time consuming. After 4-6 hours in an operating room and another 4-6 hours seeing patients, the idea that you’d go on line and spend another 4 hours communicating to other patients is not exactly enticing for most people (especially when many people on those on-line chat rooms are simply not very polite).

    This is a cultural issue. If we want to find better treatments for localized prostate cancer, then we’d better all find a way to accept that we need to be able to measure what we mean by “better”. I know what “best” is: it’s 25+ years of biochemical recurrence-free survival with no risk for side effects whatsoever. I don’t know of any treatment that I expect to become available in my remaining lifetime that will meet that standard. So how are you going to define “better” if we don’t work out how to measure “better” according to some agreed standards? The types of case series published by Walsh and Scardino (surgical) and Katz (SBRT) and Klotz (active surveillance) have been instructive because at least they have told us what is expectable in defined groups of patients … but we have no good comparative data at all. That is the only point of importance in all of this. Without accurate comparative data, it’s all just talk.

  7. Nice one, Mike, as always. Thanks.

  8. I find it very curious as I see all the information saying we need long-term studies on focal treatments, that do not work, that no one brings up this one (see abstract below). Of course focal laser ablation treatment now using advanced MRI guidance in real time is light years ahead of this study and the fact that it is being done successfully at major universities every day should make one think. I guess it depends on who is doing the thinking.

    Introduction: The introduction of breast-sparing surgery (i.e., “lumpectomy”) revolutionized the management of breast cancer. The use of lumpectomy showed that quality of life could be optimized without compromising treatment efficacy. Complications of prostate cancer treatment, including impotence and incontinence, adversely alter the male lifestyle no less than the loss of a breast does for a woman. In 2002, Onik et al. introduced the concept of focal therapy for prostate cancer. The intention was to try to limit prostate cancer treatment morbidity while maintaining good cancer results. Focal therapy is now established as a major trend in prostate cancer management although long-term data on patients who have undergone focal therapy has not been available. In this study we will present follow-up on 70 patients who underwent focal therapy using cryoablation for prostate cancer who have been followed for an average of 10 years.

    Conclusions: The long-term results of focal therapy using cryoablation appear to be equivalent or better to other more traditional therapies in all grades of disease. In this series all the risk levels remarkably had the same BDFS. The one common factor in all the risk levels was the same level of local control afforded by the ability to treat extra capsular disease and retreat those with local recurrences. It raises the facsinating possibility that the differences in survival always attributed to the inherent nature of higher grade disease to metastasize may not be true and that it is the difference in our ability to gain local control with high risk disease that may be the reason.

    Therefore, limitation of focal therapy to low risk patients is not necessary. Repeat treatment of those patients who have a local recurrence discovered, does not appear to negatively impact patient disease specific or BDF survival. Patients treated with bilateral multifocal disease appear to do as well as unilateral tumors and all grades and PSA levels, appear to have excellent results compared to other treatment modalities. Focal therapy achieves these results with minimal morbidity in terms of incontinence and potency. The safety and long term efficacy of focal cryoablation is now established. Investigators now have the data to have a comfort level to conduct comparative level 1 evidence studies, between focal therapy and robotic RP and the various forms of radiation. These results, if reproduced, will fundamentally change the paradigm of prostate cancer management.

  9. Dear Ken:

    Unfortunately what you are probably not aware of is that, nearly 20 years ago now, Dr. Onik was making similar claims as to the effectiveness, safety, and value of whole gland cryotherapy. These turned out not to be true. Whole gland cryotherapy is now a relatively uncommon procedure, and many of its early advocates have become advocates for focal cryotherapy instead. Now there is certainly a place for focal cryotherapy — particularly among older men who might not be good candidates for treatments like radical prostatectomy or external beam radiation therapy. However, not all the reported series have the sorts of results reported by Dr. Onik, and what is not exactly clear from Dr. Onik’s published data is whether it includes all of his patients from 10 years ago. If these data only include selected patients, then they are clearly not good data to rely on. And since other reports give significantly less good data that Dr. Onik, then there are other questions that need to be addressed.

    The other problem is that breast and prostate cancer have similarities but also significant differences. Most particularly, even though one may only find a single, small, positive biopsy core (even on an MRI/TRUS fusion-guided biopsy) in a man with intermediate-risk prostate cancer (let alone high-risk disease), prostate cancer is notorious for being a multi-focal disease (i.e., on pathological examination of radical prostatectomy specimens post-surgery, it is commonplace to find tumors that were never visible on biopsy — and in other parts of the prostate).

    Frankly, we are still at the beginning of trying to understand exactly who is a good candidate for any form of focal therapy and who isn’t. This is not to say that focal therapy is “bad” or “inappropriate.” All that a wise man needs to appreciate if he wants to go down this road is that we don’t know what we don’t know. And what we don’t know enough about yet is whether focal therapy is truly curative in a high enough percentage of patients. What is going on at the major academic centers you mention is commonly research to see if we can get a good handle on this. In the meantime, if a man with a small focus of intermediate-risk prostate cancer wants to have focal therapy, I for one would encourage him to go to one of the established centers that are doing such investigative work — as opposed to someone who is “selling” focal therapy (of any type) as being the latest and greatest way to treat certain types of prostate cancer. There aren’t enough data to support any such conclusion, and what data there are do not come from many of the really well-established research teams that know how to do such studies with a high degree of care and attention to detail.

  10. I think the National Institute of Health would be considered a well-established research team. I am a patient in the MRI Guided Focal Laser Therapy clinical study. The University of Texas is not doing clinical studies. They do FLAs on a regular basis and on multi-focal prostate cancer.

  11. Dear Ken:

    I would agree that the NIH Clinical Center has a well-established team, and I think it is regrettable that the University of Texas is carrying out “routine” focal therapy without appropriate long-term follow-up processes in place (if that is indeed the case).

  12. Sitemaster and Ken,

    (1) Why not ask Dr. Onik if his study included all his Cryo patients?
    (2) NIH appears to be getting excellent focal results.
    (3) I believe University of Texas does continuing follow up using MRI.
    (4) By the time focal therapies are “proven”, we will all be dead.
    (5) The almost daily studies on MRI indicate that MP MRI can locate most significant cancers.
    (6) We know that laser can destroy cancer.
    (7) We know that the side effects of laser treatment are much less than surgery or radiation.

  13. Doug:

    What’s your point? We can make statements like that about all sorts of newer therapies. However, without high-quality, long-term follow-up on really well-documented case series we won’t know anything. I look forward to seeing the 10- and 15-year data from high-quality centers like the NIH and others. I’d prefer to see randomized trial data, but it’s probably never going to happen.

    Again, I am not telling anyone not to have focal therapy. Indeed, I regularly encourage men with very small foci of intermediate-risk cancer to get an opinion from an appropriate and experienced specialist. However, I also tell them that the available data on long-term outcomes are variable and really good data are few and far between. Caveat emptor or “Let the buyer beware.”

  14. There are two things that can be proven very easily.

    — Google, “Salvage treatment for prostate cancer”
    — Google, “Side effects for prostate cancer treatments”

    Or we can believe the surgery and radiation advertising of 97% cure rate and minimal side effects. Yes it is past time for MRI scanning, MRI-guided biopsies and MRI-guided focal treatment. Now many more men have to go through 25-year-old failed treatments because the prostate treatment industry is making billions of dollars.

  15. Mike, I find it compelling that you have been active in this and other PCa forums professionally, but have stayed on ‘active surveillance” for many years. Can you please share your PSA/Gleason score/# of cores positive so we can understand your personal PCa thoughts and decision not to choose any treatment?

  16. My point is that mpMRI seems to be able to locate prostate cancer and focal therapies seem to be able to control prostate cancer, and have much lower side effects than surgey/radiation.

    For someone who needs treatment now, waiting for 10- or 15-year study results is not an option.

  17. Doug:

    And I don’t disagree with you. But you also need to appreciate that we are still going to need the data in order to prove your point. (I thought your use of the word “seem” was entirely apposite, twice.) And we still need a lot of the men who would opt for focal therapy to understand that they really may not need treatment at all because they have a high chance of having indolent disease.

    This conversation is about two quite different things: (a) What would/should an individual patient do now, given a very specific set of diagnostic criteria, and (b) do we have the data to prove that mpMRI diagnosed and guided focal therapy really is a “better” choice than whole gland therapy for selected patients, meaning demonstrably at least as effective and significantly less associated with problematic complications and side effects.

    The other issue is “who’s doing the treatment?” We all know that most urologists can’t do a nerve-sparing radical prostatectomy of the skill of a Pat Walsh or a Peter Scardino. It appears likely (although I don’t have data to confirm it) that many urologists may not be able to do HIFU with the skill of a Stephen Scionti. And I’d be very surprised to hear that the average urologist will ever be able to do an FLA with the skill of someone like Peter Pinto. In other words, it’s not just about the form of treatment, its about the skill and experience of the physician and his or her support team too — in selection of appropriate patients and the execution of the treatment.

    And in any case, see my response to “Elucidated1” below. It may help you to appreciate where I am coming from. I’ve been doing this for a very long time now. Most men still respond to a diagnosis of prostate cancer in a less than full considered manner, and then some of them become a lot more knowledgeable “after the event”.

  18. Ken,

    The move toward MRI-based diagnosis and focal therapy is a huge economic threat to urologists.

    Radiologists do the MRIs (which may largely replace biopsies) and interventional radiologists do the focal laser ablation and also do the MRI-guided biopsy (when done “in bore”, which is probably the most accurate type of MRI biopsy).

    Doug

  19. Doug:

    Actually there is a whole other way to look at this, which is that MRI-based diagnosis and focal therapy is a huge opportunity for smart urologists. All they need to do is to acquire the right equipment and hire the uroradiologists and the interventional radiologists into their practices! That’s what the large urology groups have already done with relation to the value of IMRT and I have little doubt that some of them are going to do exactly the same thing with regard to focal therapy.

  20. Mike, again, you be rockin’. You are exactly right … it is not just the treatment but who is doing said treatment. And that certainly compromises the dignity and credibility of the published studies of hundreds/thousands of procedures done … with such a wide variety of results.

  21. Doug,

    I have to say you have hit the nail on the head. A urologist who is doing $50,000 surgeries is not excited about getting new equipment, new personnel, new training, and starting a treatment which costs $16,000. It would be great to think they are concerned about the outcomes we see posted everywhere and would push forward to new technology as the National Institute of Health and forward-thinking universities are doing. The impact of reducing costs for the treatment of prostate cancer in our healthcare system would be amazing, but the impact would also be a urologist only doing surgery for the 40% of men who really need aggressive treatment. Of course it is hard to tell who needs aggressive treatment if they do not bother to incorporate new MRI scanning and MRI guided biopsies into their practice.

  22. Ken:

    I think we should be very clear that the vast majority of urologists are not getting paid anything like $50,000 for a radical prostatectomy. The hospital they work at may be charging that sort of sum (by the time they’ve charged for overnight stays, anesthesia and nursing services, operating room time and equipment, and $40 per pill for an aspirin) but the actual surgeon is probably seeing significantly less than $15,000. See this recent report.

  23. Thank you for the clarity and patience. Based on the report you posted, a total of $50,000 for surgery or newer radiation treatments would not be surprising. I realize the urologist does not get all the money but what would be your guess on the number per day and approximate amount paid to the urologists for each surgery. With some of the numbers of surgeries done by some surgeons going into the thousands and I agree a man would want all the experience in a surgeon he could get since 500 surgeries is considered a baseline for expertise. Let’s take a surgeon doing 8 a week at $12,000 each.That’s $96,000 a week not counting his biopsy and office income. Factor in the cost of salvage and side effect treatments and what is our health care system paying out to our current prostate cancer treatment system. It is not my intention to be argumentative but to bring attention to the National Institute of Health’s mission. Early detection, including MRI, better tools for active surveillance, early focal therapy using MRI guidance and cost-effective treatments our healthcare system can afford. I think if you would request an interview with Dr. Walser, Chairman of Radiology at the University of Texas, you would be surprised to find that $16,000 includes MRI scan, MRI-guided biopsy, MRI-guided focal laser ablation and the one-day outpatient stay. You will also be delighted to find he discloses all his patients outcomes. An interview with Dr. Peter Pinto could be quite helpful as well. I know we could all wait 15 years for data but if you consider the current prostate treatment system does not release all it’s patient’s outcomes, do we really know what we are getting for our prostate cancer treatment dollars now? You have a lot of expertise at what you do, please consider stepping out of the accepted system and become a reporter for the future.

  24. Dear Ken:

    Alas, what I do is a labor of love. I also have a full-time job and other commitments. If I started interviewing people on a regular basis on (only) all the things you are talking about, I would have no life left at all! I am not, by any manner of means, a full time journalist!

    My goal is to try to interpret available information for people and put it into “simple English”. The economics of cancer diagnosis and treatment in America is, on its own (regardless of outcome data) a vast and complex issue. As indicated in the article I referred you to yesterday, pricing is all over the map and while Dr. Walser may be able to charge just $16,000 for the services you describe, I can assure you that others elsewhere would be charging more or possibly even less.

    Because I have done other research related to this topic, I can tell you that the fees charged for a radical prostatectomy by the urologist alone range from a high of about $75,000 to a quite common low of more like $3,500 to $4,000. I have no idea what the “average” might be for a urologist in De Moines, Iowa (for example). It varies depending on who the payer is for starters. Even the standard Medicare reimbursement for an RP varies from region to region across the country. I would also tell you that most really good urologists don’t like to do more than two RPs a day on 3 or 4 days a week because otherwise they are not able to retain enough detail about each operation to be able to advise the patients appropriately afterwards. Of course there are surgeons that claim to do 3 and 4 operations a day, 5 days a week, but those surgeons are often working at what I consider to be prostate cancer “factories” where several surgeons are working under the supervision of a lead “expert”. The lead expert may only do a small and complex part of each such operation as part of the process of teaching others.

    Please appreciate that no one is suggesting that current treatments for any stage of prostate cancer are good enough. They aren’t. But at the other end of the scale it would be utterly unreasonable to start treating everyone with focal therapy based on the available data. And while Dr. Walser and others like him are quite certainly collecting data on the patients they have treated, those data are not yet published. One of the things that I am quite certain about is that until we have really good, reliable, published data with at least 5-year and preferably 10-year outcomes, we are not going to be able to persuade the payer community to reimburse for this type of treatment on a wide scale. And without reimbursement, there will be no significant changes in clinical practice.

    I can assure you that when we start to see reliable published data from Dr. Walser and others, I shall be commenting on those data on this web site, but I am not in the business of recommending investigational therapies to people unless there are very good reasons to do so (on an individual basis). I regularly write about the existence of such treatment types and the fact that we need more data before it would be possible to actively recommend them to the majority of patients. You may have a different opinion. That is your right, but at present there are really very few urologists in the country who have a high level of skill and experience in the use of focal therapy, and the few data that I am aware of from places like the University of Colorado, where they have been doing focal cryoablation for nearly 7 years now, are honestly not as compelling as you might think.

  25. Mike,

    There is no place on the internet forums where patients can find “interpreted” current information on prostate cancer abstracts and treatments as one can find here. Your skill at spelling this out for all of us is without peer.

    As I shared before … I still wish urologists would participate in the discussions here and on other forums. So far, it is only on Medscape articles/abstracts that I see them participate. Dialog between the stakeholders is one way to break down the translucent glass ceiling that seems to protect physicians but hinder patient understanding of the choices they face.

  26. I think Ken is exactly right. For prostate cancer patients who are not good candidates for active surveillance, now is the time for them to pull the trigger. They cannot wait for 5- or 10-year studies on comparative treatments. Like me, many have to pull the trigger now … and if they don’t believe that their standard recommended choice of radiation or surgery is right for them … then plan B it is.

  27. Jim:

    I am more than happy to see anyone with a brain participate in these discussions … and every so often some physicians do (up to and including people like Michael Kattan) … but what I have no interest in doing is begging the medical and scientific community to participate. You wanna go beg them, you go right ahead!

    :O)

  28. I hate to be rude about this but as an ex-educator I am troubled by the comment “anyone with a brain” that is probably full of unintended condescension. How do we help those who in your perception don’t have a brain but are still at prostate cancer risk, do not know how to meander though the hoops generated by the urology/radiology profession? And for me that was the problem. I could not disaggregate and differentiate the data, the choices that were best for me. And I have an MA in human development.

  29. Jim:

    And that is exactly why I report information about the existence and availability of these types of treatment. But I would tell anyone with high-risk prostate cancer (of however small a focus) that focal therapy for them was near to insane … so we are talking about men in a relatively narrow range, not “everyone” diagnosed with prostate cancer; rather men with a small amount of low-risk disease who are not good candidates for active surveillance and men with a small amount of intermediate-risk cancer in a highly defined section of the prostate (and hopefully nowhere else). Taken together, this is not a very high percentage of the 230,000 men who get diagnosed each year. It might be no more than 15%.

  30. Hang on a minute … We were talking about doctors commentating on this blog … Not about how to inform and educate those who know nothing about prostate cancer, which is a whole different subject. I expect doctors who diagnose and manage prostate cancer to have a brain … whether they use it well or not is then a judgement call! You can’t change the subject like that!

    The failure of our society and educational system to provide men with any significant guidance about their health risks over time is a disaster. I don’t care whether you barely made out of 8th grade or you have a DSc in microanalytic cryptography from MIT. A society like America (and most of the rest of the supposedly “civilized” world for that matter) should have worked out by now how to educate its population about critical health issues over time. The Scandinavian nations do at least try. The average American male, by contrast, knows where is his penis is and two its potential uses … and that’s about the level of his total health knowledge (unless he gets sick).

    Very few people who haven’t already been affected in some way by prostate cancer are reading this blog. They may get here fast when they get diagnosed, and better still they may sign up to belong to our social network, where they can get walked (on an individual basis) through the options that make possible sense for them (including focal therapy if and when appropriate). However, I am not delusional. I am not in the business of trying to educate all men about all the health risks they should be aware of (starting at about 16 with the fact that if you eat badly, smoke cigarettes, start drinking heavily, and drive cars fast while texting and shooting cocaine you may never grow old enough to even have to think about whether you are at risk for prostate cancer!) THAT is something that our sociopolitical leadership seems to be utterly unwilling to address.

  31. Thanks, Mike. I realize that this blog only has a tiny fraction of prostate cancer patients actually finding and reading it … considering that out 240,000 newly diagnosed males every year … only a few hundred ever find PCIL, Us TOO, and/or YANAnow in the first place. But it is so tough to disaggregate data that is cogent to one’s situation … and yet so serious. And yet there are no forums for those without a brain that has physicians answering questions, and directing others to solutions … unless one counts the forums here and on Us TOO.

  32. In my last scan of clinical studies on surgery and radiation it appeared that about 60% of the men were classified as very low, low, and intermediate. That leaves the 40% who should be there because of risk and it also makes the studies look better. There are a vast number of men who qualify for MRI-guided FLA, which can be repeated without raising the side effect bar and still leaving all salvage treatments open. All it takes is a 3 T mpMRI scan and a MRI guided biopsy to find out. Perhaps we could agree that at least a man could have the above tests done and have better information before doing life-altering radical treatments.

  33. Since I am only too well aware of the time and effort that has to go into doing this … I can’t say that I am entirely surprised! And I don’t have a $400,000 educational loan to pay off after spending 7-10 years training to become a Board-certified urologic oncologist or medical oncologist!

  34. Question

    Do most males over 60 have at least a small focus of high grade PCa?

    I thought it was the predominant Gleason grade that counted.

  35. Ken:

    I will tell you right now that I know of no data at all that justify multi-focal FLA, even if people are doing this, and even if there are patients who want to try it. I therefore don’t agree with your premise that there is “a vast number of men” who qualify appropriately for this use of FLA or any other form of focal therapy. On the other hand, I will defend to the death the right of those with multifocal disease who are nuts enough to want to try it — assuming that they are trying it with a full appreciation of the potential risks and benefits!

    I would also point out that this does not just take “a 3 T mpMRI scan and an MRI guided biopsy” to find out whether one is a good candidate. It takes all of the equipment PLUS some people with great skill and experience in the use of this equipment … and there are very few of these people as yet.

  36. Doug:

    Huh? Where did you get the idea that “most males over 60 have at least a small focus of high-grade” prostate cancer?

    Of course they don’t. Males of 60 have a 50-60% chance of finding at least one focus of prostate cancer in their prostate if they die for any other reason and their prostate is carefully examined on autopsy. Most of those foci are not high grade, which is exactly why most men in their 60s who get diagnosed with Gleason 6 prostate cancer (especially if it is only one or two small cores) will never have a survival benefit associated with immediate treatment.

  37. I think the point you made earlier about getting the best doctor for radical treatments apply to MRIs as well. I am familiar with the process after a few years working with the National Institute of Health. I am also familiar with the concept that focal therapy is not suited for multi-focal cancer, but then again what else can the current prostate treatment system say. If you reread the focal cryo study you will find it worked excellent for multi-focal. Yes cryo is old news but new focal technology is far more precise, so yes I and many others will destroy just the cancer and not our prostates. Should we need to get rid of another small lesion in a few years, yes we will repeat the afternoon out patient FLA. In the mean time I’ll follow a careful active surveillance program after my FLA of years ago including a MRI at every 18 months. Risks? I do not wear diapers and I enjoy a wonderful intimate life with my wife.

  38. Sitemaster

    I was just asking a question.

    If the below is correct, only the primary and secondary grades are used to determine the Gleason score.

    So if primary grade was 3 and secondary was 4, the Gleason would be 7, even if a small focus of 5 was found (I believe the tertiary score is not generally reported).

    What am I missing?

    Primary, secondary and tertiary grades [edit]

    A pathologist then assigns a grade to the observed patterns of the tumor specimen.
    Primary grade — assigned to the dominant pattern of the tumor (has to be greater than 50% of the total pattern seen).
    Secondary grade — assigned to the next-most frequent pattern (has to be less than 50%, but at least 5%, of the pattern of the total cancer observed).
    Tertiary grade — increasingly, pathologists provide details of the “tertiary” component. This is where there is a small component of a third (generally more aggressive) pattern.

  39. And that is the issue with 3 T mpMRI. … There are not many people who are trained well enough to read them. I had a well-known Los Angeles-based urologist, with awards and plaques all over his walls, mis-read my ultrasound!

  40. Doug:

    (1) Good uropathologists now always provide information about the presence of any tertiary grade cancer. This is recommended in uropathology guidelines. (Of course this doesn’t mean that all pathology labs follow such guidelines.)

    (2) The presence of any tertiary Gleason pattern 4 in a specimen for which the primary and secondary patterns were both Gleason 3 represents an upgrade (although there is no consensus at this time about the degree of that upgrade). Similarly, the presence of any Gleason pattern 5 in a specimen for which the primary and secondary patterns were either 3 or 4 represents an upgrade that is considered to be significant.

    Thus, if a patient is diagnosed with Gleason 3 + 3 disease and there is no sign of any tertiary pattern 4 or 5, then he is Gleason 6. However, the presence of any tertiary pattern 4 or 5 in specimens from such a patient would (arguably) require him to be upgraded to at least Gleason 3 + 4 = 7. A man who had Gleason pattern 4 + 3 and a tertiary Gleason pattern of 5 might arguably be upgraded to Gleason 8 … but there are no rigid guidelines about exactly how to make such interpretations as yet — only expert opinion from people like Epstein at John Hopkins.

  41. Thanks … that helps me understand the current system.

    That said, I would guess that virtually all the autopsy studies were done prior to this newer methodology, and a 3 + 3 with a very small focus of 4 or 5 was reported as a simple Gleason 6.

  42. Doug:

    The most recent autopsy series that I am aware of was published in 2013, but it is not clear to me from the available information whether the data included tertiary grades (although they ought to have done by then).

  43. Mike,

    I am a new visitor to PCIL.

    In your post on July 10 at 10:54 you stated, “I would tell anyone with high-risk prostate cancer (of however small a focus) that focal therapy for them was near to insane.”

    I don’t think I am insane, but the classification of my prostate cancer as high risk with a biopsy-proven Gleason score of (3 + 5)=8 might suggest I was a poor candidate for focal laser ablation. In spite of the Gleason score, the biopsy results were only positive for 15% of two cores on the left. CT and bone scans showed no evidence of cancer outside of the gland. With a predominant Gleason grade of 3 coupled with a classification of T2aN0M0 I preferred to think of my situation as more of an intermediate risk.

    An imaging study with DCE mpMRI echoed the biopsy result with the radiologist’s opinion that clinically significant cancer was present on the left side. The radiologist also called attention to a previously undiscovered area of suspicion on the right. The possibility of multi-focal disease complicated the decision process as the new area of suspicion required a targeted biopsy.

    I sent the DVD with the imaging results and the radiology report to Dr. Walser at UTMB for review. I was delighted when Dr. Walser informed me that my prostate cancer was treatable with focal laser ablation. I chose that path as I very aware of the co-morbidities associated with RP and radiation. My reading also suggests that both cryotherapy and HIFU are not problem-free.

    The biopsy of the new area of suspicion on the right confirmed a small lesion with a Gleason score of 6 on May 5. Both that area and the cancerous lesion on the left were then ablated by Dr. Walser. I am looking forward to the results of the follow-up in early November. The FLA procedure was pain-free. I wish I could say the same for the three TRUS sextant biopsies I had over the years. There have been no post-procedure urinary or ED issues.

    I consider myself to be in the same posture as the prostate cancer patient managing the disease with active surveillance. I will continue PSA exams every 6 months and will have an annual DCE mpMRI for as long as may be relevant. If we missed ablating some portion of the cancer another morning in the MRI will likely take care of the problem. As long as I am vigilant my poor layman’s opinion says the odds of this disease metastasizing are very, very low.

    Joe

  44. Dear Joe:

    You may have missed the bit where I also wrote, “I will defend to the death the right of those with multifocal disease who are nuts enough to want to try it — assuming that they are trying it with a full appreciation of the potential risks and benefits!”

    Having said that, I wouldn’t be getting a PSA test every 6 months if I was you … I would be making darned sure I got one every 3 months. If you have another tiny focus of Gleason pattern 5 disease somewhere (which is distinctly possible) you are going to want to know about it as soon as you can!

    I would also tell you that just because Dr. Walser told you that your cancer “was treatable” with FLA does not necessarily imply that it is “curable”. These are two very different ideas.

  45. What treatment would that be that cures prostate cancer?

  46. Mike,

    Thank you for your concern. The 6-month interval for PSA testing was the time indicated by the post-FLA discharge instructions. I believe the original protocol for both Dr. Walser and Dr. Oto prescribed the first post-procedure PSA test be done at 3 months as you suggest. I am not sure when or why the protocol was changed or whether the revised protocol was intended to apply to higher risk patients. It may be that residual trauma and hemorrhage from the FLA procedure skewed the PSA tests results in such a way as to cause excessive and unwarranted patient anxiety. I will make inquiry to see if Dr. Walser suggests something different for my situation. Three months may well be the appropriate interval after the initial post-procedure PSA.

    All of life is a risk. The possibility of recurrence after initial treatment for prostate cancer is a given irrespective of the method of treatment. The Han tables were expressly designed to measure that risk following radical prostatectomy. Had I undergone radical prostatectomy my risk of prostate cancer recurrence is 10% at 3 years and 37% at 10 years: not great numbers by any means. I suspect the odds may be a little worse with FLA simply because most of prostate tissue remains. Assuming the ablation zones completely eliminated the existing cancer, the conditions that left me predisposed to this disease likely still exist. I had and have no illusions about cure. While researching treatment methods I found the practice of certain physicians to announce patients as “cured” immediately after completion of a procedure particularly annoying. I understand the marketing aspect and it may be correct to say “cured for the moment” but such statements are misleading and unprofessional.

    Each patient is unique. I was particularly fortunate that my cancer was contained in the gland and not near the urethra and nerve bundles. Had it been otherwise FLA would not have been an appropriate choice.

    My selection of FLA as first-line treatment was motivated by a desire to maximize quality of life and the expectation that, at age 66, one of my sundry other conditions would probably do me in before prostate cancer. My wife of 41 years and I still enjoy fairly regular intimacy and hope to continue that way as long as possible. I had a secondary motivation as well — somebody has to step up to prove the efficacy of the procedure, or in this case, many somebodies. Doing prostate FLA on patients with a Gleason score of 6 is essentially irrelevant except as a psychic balm. Research indicates patients with Gleason scores of 6 will not experience metastatic prostate cancer from the Gleason 6 lesion and in most instances would be better off following a program of active surveillance. Logic dictates the most appropriate candidates for FLA will be patients with organ-contained cancers of Gleason 7 or 8. Ergo, I have offered myself up to the advancement of science with a major qualification — I will religiously follow a schedule of active surveillance and opt for another treatment if, and when, it becomes necessary.

    Joe

  47. Joe,
    There are about 1200 posts on FLA on <a href=http://www.inspire.com/groups/us-too-prostate-cancer/discussion/focal-laser-ablation-patients/?reply_sort=asc&page=last#repliesthe Inspire web site. Please consider adding your story.

  48. Ken,

    I have been an occasional contributor at Inspire.com under the focal laser ablation and active surveillance topics patients using the name JoeBoca. Thanks for the comment.

    Joe

  49. New to this blog.

    So you can understand a little about me … I had three bilateral Gleason 6 lesions. One tumor was near the urethra and was about to create problems and limit future treatment options. Not a clinician. I am a health actuary whose training is health data, outcomes, risk, etc.

    In the spirit of full disclosure …

    I believe random biopsies are a barbaric anachronism that prove nothing. They don’t find all of the clinically significant tumors. They can produce infection, pain and hemorrhaging, which clouds MRIs. If PSA is high, 3 T mpMRIs should be used with an experienced radiologist as a first step with an MR-guided biopsy, as needed, to get a starting point for diagnosis and treatment plan. Not convinced? … name another organ where invasive procedures are used before noninvasive imaging?

    I had FLA with Dr. Walser. Lesions are gone. No side effects. Immediate return to full normal daily activities. On full AS. Yep, I know it is not accepted by urologists for many reasons.

    But, let’s say someone you have low- to intermediate-grade prostate cancer. And let’s say, AS is not for you — even though it may be the most logical choice. So what do you do?

    A prostatectomy is “proven” based on $$$$$ of lobbying/PR and tons of experience. Proven to leave positive margins about 25% of the time. Side effects? Proven to shorten penis by one inch. Proven to have high risk of ED for some time. Proven to have long term side effects about the same as radiation — which is ugly. Proven to have, according to some nomograms, recurrence at 9% for low grade (1 lesion, PSA 6, GS 6) and 54% for intermediate (2 lobes, PSA 6, GS 7). If there is recurrence, proven to have bad treatment options with low success rate and high side effects rate.

    Sure, I have friends who had surgery with few problems. if people understand the real cure rates, risks, etc., I have zero problem with their right to choose surgery. They may be lucky. Also I have friends with post-surgery side effects, recurrence and poor options.

    So what’s my point? Agree that FLA is unproven. But all the studies and experience to date is that it destroys the lesions. And it is FDA approved in the US. Virtually no side effects. What is the problem? Sure, you still have a prostate, so you can get more lesions. So what? … You zap them again. It is not like the routine failures of prostatectomy and radiation, which offer bad salvage options.

    At the risk of oversimplifying …

    If prostate cancer has spread, both FLA and prostatectomy are not good options. If PCa has not spread and particularly if the Gleason score is low to intermediate:

    (1) Prostatectomy has greatly overstated cure rates, high side effects risks, and a poor salvage situation.
    (2) FLA is safe and effective and virtually no risk of side effects. If future lesions arise, maybe AS or FLA or possibly another even better option will be available. In the mean time, it buys you time and quality of life.

    I understand the urologist’s position. We need 20 years of experience. Lots of clinical trials. Randomized studies. Longitudinal tracking. Risk adjusted.

    I totally agree that we need more clinical trials and more research related to FLA. However, there is no need to fear FLA if you are a good candidate now.

    And, Medicare and insurance need to reimburse for FLA. How many clinical trials did we have before FDA approved robot assisted surgery? Zero. How many randomized trials will we ever have with surgery? Zero.

    Be well :-)

    John

  50. John,

    Men are beginning to learn about the real outcomes of surgery and radiation. My challenge to the multi-billion-dollar prostate industries, release all your outcome data and let’s compare it to your advertising. In the meantime let’s pray men will include research into MRI scans, MRI-guided biopsies, and MRI-guided focal laser ablation and not rely on sales pitches without regard for what is actually happening to so many men who have followed the old school of cut it out or burn it up with radiation. Technology is changing thanks to the National Institutes of Health and forward-thinking universities.

  51. Dear Ken:

    With all due respect, it is pretty insensitive of you to state that, “Men are beginning to learn about the real outcomes of surgery and radiation.”

    Tens of thousands (if not hundreds of thousands) of men have been all too well aware of the problems associated with surgery and radiation therapy for the treatment of prostate cancer … for years and years and years. What you are ignoring (or simply don’t realize) is that they didn’t have the options that have come available in the past 4-5 years (and that are still only available at a very small number of centers). The first-generation forms of focal therapy (which date back to the early 2000s) weren’t particularly effective. Newer technologies have made these forms of treatment much more viable only in the very recent past — but there are still very few physicians who know how to use those technologies well, and the insurance industry is still not compelled to cover the costs of these therapies because of the lack of really good, published outcomes data.

    If you want to do something to help men avoid over-treatment, do something really useful, which would be (a) to persuade more men to enroll in studies of FLA and other forms of focal therapy and (b) persuade more physicians and high-quality research centers to learn to use the new technologies and implement such studies. That way we will get the data we need to prove that these forms of treatment have the outcomes that we all hope that they do. Comparing historic outcomes data to the advertising done by hospitals where some urologists work (rarely by the urologists themselves) isn’t going to accomplish anything. We need actual data on the effectiveness and safety of FLA and other forms of focal therapy in well-defined categories of patient. … You may not like this, but it is a simple fact.

    I would also point out to you that a poor surgeon with a laser is still going to be a poor surgeon, and will get poor results when he (or she) uses FLA. A critical key to the effective and safe use of FLA will still be the skill and experience of the surgeon (or radiation oncologist) who carries out the procedure and the uroradiologist responsible for taking and reading the necessary imaging scans.

  52. With all due respect, men are now just learning about the real outcomes of surgery and radiation. The prostate treatment industry has never released all its outcomes, so how were men supposed to know what they were really getting into. Again with respect the prostate treatment industry has been over-treating 1000s of men who qualified for active surveillance well before focal therapy came into the picture.

    By your own admission untold thousands of men are well aware of the problems associated with surgery and radiation therapy for the treatment of prostate cancer … for years and years and years. I have not seen any change in treatment advertising and yes comparing real outcomes concerning what a medical center has been doing to men for years and years and years, to what they tell men is going to happen to them now in their advertising is more than important, it is imperative.

    The only thing that will bring this to light is all of us researching the path to better prostate cancer treatment which does not reside in using the old tools of a scalpel or radiation. I can assure you the National Institutes of Health is training some of our best doctors for the task ahead and speaking for myself and many others who have been blessed by new technology, we are in the midst of doing just what you suggested about actually helping men (new studies, patient and doctor awareness are in the works), not just debating 30-year-old ideas which have adversely effected those thousands of men you spoke of, and the thousands of men to come. Now that is a simple fact.

  53. Dear Ken:

    There are three quite different things going on here.

    (1) I and many others have argued for years that hospital and physician advertising should be subject to the same sorts of regulations that are placed on pharmaceutical and biotechnology companies … that any direct to consumer advertising should be demonstrably supported by high quality data and be required to give full disclosure of all significant risks for complications and side effects related to the treatment in question. This goes well beyond prostate cancer and should be the norm for all forms of promotion of medical treatment. Such a requirement would address your issue about advertising and outcomes because public access to relevant outcomes data would be a necessity of the ability to assess whether such advertising was actually accurate.

    (2) The promotion of invasive treatment by the “prostate cancer industry” is a problem associated with beliefs in different sets of data and the entire way our healthcare system and society works. There is no consensus within the treating community about most of the available data … largely because the available data are lousy. And because, as a society, we tend to believe in the rights of the individual (including the individual medical practice, hospital, or company) to be able to do whatever they like when it comes to “free speech”, individual people and companies take advantage of that “right” to promote their interpretation of the available data. But some really good data on the risks associated with the side effects of treatment have been available since 2008, when Sanda et al. published the results of a large, prospective trial in the New England Journal of Medicine … and those data were based on outcomes at some very highly regarded centers. It never fails to amaze me how few people are even aware of that study … despite its wide original publicity.

    (3) The fact that low- and very low-risk forms of prostate cancer are associated with a very low risk of prostate cancer-specific mortality has been well understood for decades, and were actually clearly proven by Albertsen et al. in 1998 (although neutral observers had understood this for years). This is by no means news to anyone who does an even half-decent job of researching their options when it comes to the management of prostate cancer: but most men don’t. They hear the word “cancer” and feel obliged to “do something” because they assume (wrongly) that it is going to kill them, which, in the vast majority of cases (about 205,000 of the 230,000 cases diagnosed in American each year) it won’t.

    No one I know in the advocacy community disagrees with your premise that men should do more to actually understand what they are dealing with (from the moment they decide to have an initial PSA test). Getting most men to actually do that is extremely difficult, however. Many of us have been trying to get men to do that for 20+ years, with a notable lack of success — because most men don’t think about their health issues at all until it is too late. That’s a problem with our social and educational systems.

    On top of all of that, while we have an insurance system that doesn’t cover the costs of what they consider to be “investigational” and “experimental” treatments, it is impossible for most men to be able to get treatments like FLA and other forms of focal therapy for the simple reason that they don’t have either the financial resources or access to a capable provider (or both).

    I am all in favor of men who have the ability and the resources to do it seeking out high-quality providers of focal therapy … so long as they recognize that the available data are still limited, and that even the best physicians are still learning (as exemplified the other day by Dr. Walser’s public statement that he would no longer attempt FLA on any man who had had prior radiation therapy because of a very severe complication in one such patient). We need all the data we can get on the outcomes of such men over time. However, I would also point out that many of the most appropriate candidates for FLA don’t actually need immediate treatment at all. If we over-promote the use of FLA without good data comparing the outcomes of FLA to expectant management in appropriately identified patients, we will be continuing a 40-year pattern of over-treatment in most of the 230,000 men who are diagnosed with prostate cancer each year.

    As Willett Whitmore (one of the founders of the subspecialty known as urologic oncology) was asking his peers some 30+ years ago now with regard to the diagnosis and management of prostate cancer, “Is a cure possible in those for whom it is necessary, and is it necessary for those in whom it is possible?”

    We have made some progress in answering this question … but by no means enough.

  54. Thank you for your well thought out response. The bar for what is appropriate for FLA treatment has been raised in the last 12 months making it more definable as a bridge between active surveillance and radical therapies and for those on active surveillance who would feel more at peace with treatment without the high risk of side effects.

    Also thank you for bringing up Dr. Walser’s public statement concerning a man who found himself where the radiation industry told him he would not be, with recurrence and with poor options for salvage treatments. I hope as time goes by, we will begin to see all the positive outcomes of Dr. Walser’s work, when FLA was used as a first treatment option, printed in your work.

  55. I should add it is hard to get a man to look into actual outcomes when the “well respected doctor” is telling the patient the opposite and rushing him into treatment based on a flawed PSA number, 12-point blind biopsy, and the doctor’s finger.

    I do appreciate the information you have just been posting here and in other discussions concerning real outcomes. Perhaps men will at least pause and begin to research.

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