Dutch urologists say prostate cancer screening “cannot be justified”


A new review by specialists from Erasmus University Medical Center, just published in Prostate Cancer and Prostatic Diseases, states categorically that mass, population-based screening  for prostate cancer “cannot be justified yet in the context of a public health policy.”

This review, by van Leeuwen et al., may be ruffling some feathers in Rotterdam specifically and in the Netherlands in general. Several of the leading participants in the European Randomized Screening Study for Prostate Cancer (ERSPC) came from Erasmus University Medical Center (EUMC) in Rotterdam, as do the authors of this specific article. Initial European reports — along with statements from individual investigators — had suggested that the results of the ERSPC did indeed justify widespread prostate cancer screening in Europe. However, the senior author of the current review, Dr. Chris Bangma, was a leading investigator in the ERSPC and is also the head of the Department of Urology at EUMC.

van Leewen et al. are careful to note in their review that widespread prostate cancer screening — when carried out using PSA tests and digital rectal examinations — does most certainly lead to a beneficial shift in the clinical stage at which patients are initially diagnosed and (based on the ERSPC data) does lead to a reduction in prostate cancer-specific mortality. However, they, as have others, note that there are major, problematic consequences of the widespread application of  PSA testing:

  • A large increase in the cumulative incidence of prostate cancer
  • A significant cost associated with diagnosis and treatment of potentially indolent or at least not clinically significant disease
  • A significant impact on the quality of life of men who are arguably being “over-treated”

This review is not going to “sit well” with men who believe that prostate cancer screening “saved their lives.” Nor will it “sit well” with those members of the urology community that believe that a single death from prostate cancer represents medical failure.

The “New” Prostate Cancer InfoLink, however, has a different “take” on this issue.

In societies where there has never been any significant attempt to identify men at risk for prostate cancer, the PSA test and the DRE offer an excellent opportunity to identify many patients who might otherwise only be diagnosed with incurable metastatic prostate cancer. The data from the Göteborg screening study earlier this year clearly demonstrate this benefit in a highly defined community where there had been no prostate cancer screening prior to the initiation of that randomized study. It is likely that if one carried out a similar study in a city like Kano in Nigeria or Istanbul in Turkey today, one might still see similar result because the vast majority of men in those cities have probably never had a PSA test or a DRE. If you re-did the same study in Göteborg today, we suspect you would get a very different outcome!

Once initial, widespread PSA testing has identified bulky low-risk, intermediate-risk, and high-risk patients with relatively easily identified prostate cancer, the value of the PSA test in helping to identify patients with smaller amounts of low- and very low-risk prostate cancer (Gleason 6 disease, a PSA level < 10 ng/ml, clinical stage T2a or less, and probably no more than 2/12 positive biopsy cores) starts to become much less productive. We know that large numbers of these men (of the order of 30-40 percent) will live for 15-20 years with their disease without it ever reaching clinical significance, even if it is never treated.

If we are to be able to take the next step in eliminating the clinical risk for prostate cancer, we clearly need to be able to identify, early on and with great accuracy, the men who are going to have clinically progressive disease that may become metastatic, not just everyone with a few prostate cancer cells in their prostate. The PSA test and the DRE have no significant role to play in identifying these patients. They simply aren’t specific enough tests. We need to focus our attention on the potential to find new tests which do have that degree of specificity and selectivity.

We are forced by circumstance to do the best we can clinically with the PSA test for the time being, but we believe Bangma and his colleagues are correct, in the context of public health policy. If we are ever to radically change the morbidity and mortality associated with prostate cancer, we need a test that will accurately identify patients at risk of progressive disease long before it has the potential to become progressive — and that needs a whole new way of testing for risk of such progressive forms of this disease.

For 30-40 percent of the men diagnosed in the USA today, at the time of diagnosis, their prostate cancer is a mild and chronic disorder that will never significantly impact their life. But aggressive treatment for such an indolent form of prostate cancer can and does significantly affect the quality of their lives. Even annual biopsies over several years in a rigorous active surveillance program have side effects. It is time for us to seriously rethink our priorities as an advocacy community. The men we need to find and diagnose early are those who will otherwise go on to have all of the problems of the men being diagnosed with locally advanced and metastatic disease prior to the advent of the PSA test. And we need to be able to manage and treat these men in ways that will eliminate their risk for progressive disease over time.

26 Responses

  1. Sitemaster makes two points in his post: (a) We need better tests than PSA. (b) PSA and DRE are important for detecting men with low-, intermediate- and high-risk Prostate Cancer.

    I don’t think anybody can or will argue with the first point. We do indeed need better tests. The conclusion of the second point should be that men need to be screened. Otherwise, how does one know if they are low/intermediate/high risk.

    The problem is — and I am tired of repeating myself — one of over-treatment and not of over-diagnosis. The 30-40% of men who are diagnosed with indolent/mild/low-risk cancer should be on active surveillance. I fail to understand how else can they monitor the progress or lack of progress of their disease.

    Sitemaster correctly says, “The men we need to find and diagnose early are those who will otherwise go on to have all of the problems of the men being diagnosed with locally advanced and metastatic disease.” At this time, the only method we have to do so, is active surveillance, which is based on a combination of PSA testing and biopsies.

    Until a new method is suggested, I think the advocacy community needs to continue to support PSA testing.

  2. Dear Reuven:

    With regard to the use of PSA testing today, what I actually wrote above was that, “We are forced by circumstance to do the best we can clinically with the PSA test for the time being.”

    It is not a matter of supporting or not supporting the PSA test today. It is about doing our best to diagnose those who need to be diagnosed.

    The advocacy community, in my view, is doing itself a dis-service by “supporting” the PSA test. What we need to be doing is making it very clear that we are not satisfied with the PSA test at all! While we continue to “support it” we fail to raise the pressure for development of something much better!

  3. I DON’T UNDERSTAND OPPOSITION TO PSA TEST AND SCREENING IN THE CONTEXT OF ACTIVE SURVEILLANCE

    I too would like to see a test even better than the PSA test, but in the meantime, I’m convinced we need to enthusiastically support screening, but in the context of active surveillance as the go-to approach for low-risk men — not mandated, of course, but strongly supported.

    I just don’t see the problem: screening, plus well-implemented education about active surveillance coupled with both screening and diagnosis, bolstered by powerful research findings from numerous centers researching active surveillance, SOLVES the real current problem of over treatment. I’m solidly with Reuven on that.

    While a statistical snapshot of treatment choices in mid-2010 would still probably find many US low-risk, newly diagnosed men rushing to major treatment, I’m convinced that is already changing. The mighty levers of change are the convincing and consistent findings of the major active surveillance programs, and the amplification and broadcast of these findings through the endorsements of organizations like the American Urological Association, the National Comprehensive Cancer Network, the Prostate Cancer Research Institute, and the National Conferences on Prostate Cancer series. The word IS getting out, and we are already seeing evidence of that in our support groups and online.

    I understand Sitemaster’s belief that we need to do the “best we can” with PSA at present. Where some of us differ is that we believe that PSA plus active surveillance is a powerful, highly effective combination NOW! You can make a good case that prostate cancer is the envy of the cancer world because of the PSA test. Sitemaster, I admire what you do everyday, especially your observant and thoughtful approach to issues, but I’m hoping Reuven and I can win you over on the PSA issue.

    I’m personally convinced that our best focus is on implementing what we already have, particularly active surveillance, rather than on trying to push an improvement over PSA. I was in the audience at a Congressional hearing where that matter was effectively presented as a choice, and it sickened me to hear some of the testimony that denigrated our current capabilities, including screening (including a mistaken hyping of the screening studies published in the NEJM by Dr. Otis Brawley in his role as a medical director for the American Cancer Society), in the interest of over-pushing research for a new and improved screening/diagnostic tool. I believe we can and should do both, but I would dearly like to see us free ourselves from fairly widespread denigration of current capability that is remarkably effective! I realize it’s an easier sell for research to develop something new if the current technology is not working well, but it’s just not true. Don’t we risk a real hit to our credibility as a survivor community if we are flat footed on that and are called to account?

    Could I suggest just one edit to the title of this article? I would like to see the word “yet” added at the end. Isn’t that in effect what the study actually said, rather than discouraging screening? Moreover, it ties in with the grossly inadequate lead time in the ERSPC and to the likelihood that more mature results will increasingly show the advantage of screening.

  4. I was probably one of the “intermediates” — PSA went from 3.6 to 4.3 in 1 year; 6 of 12 cores tested positive; Gleason score of 3 + 4 = 7. I had RP 19 months ago. Had I not been having annual screening, I would probably still have prostate cancer and would have never have known it until it was “too late”. Yes, I am living with the side effects of my surgery; yes, my life is different; but, yes, the quality of my life is much better than that of a man suffering through the latter stages of prostate cancer because it was not diagnosed in time!!

    I suspect that those of us who may fall in the 30-40% of over-treated men would much rather be in that group than in the 60-70% of non-treated men who should have been. What the “advocacy community” needs to do is stop crying about the men who might be “over-treated”, and start celebrating with those of us who are now cancer-free because we were checked! This constant squabbling and all these contradictory news releases only serve to guarantee that some men will continue to put off testing until it is too late. Sure, PSA testing isn’t perfect — say so, but also say that it’s the best we have right now and encourage men to get checked with the best we have until something better comes along, before they die from an undiagnosed case of prostate cancer.

  5. We can’t stop testing while we look for better tests. I can address two issues at the same time, and I bet you can too!

  6. Unfortunately right now there is no way to determine the people who need treatment and the ones that don’t. So we err on the side of caution with almost everyone. Sure you can make an educated guess about some individuals and determine they need treatment, i.e., the more advanced cases. However, there is no one on this planet that can look a person in the eye and tell them that their low risk prostate cancer is never going to kill them. The only people complaining that we are over-treating prostate cancer are the people that don’t have it. According to the institution that treated me, if I did nothing at all my chances of death from prostate cancer in the next 20 years was about 2.5% depending on who you believe. If I got treated my chance of death from prostate cancer went to 0%. My answer was “where do I sign up for treatment?” The possible side effects everyone is so worried about aren’t really that big of a deal in exchange for your life.

    Oh well, “What’s a girl to do?”

  7. I’m sorry. Who suggested we should “stop testing” while we look for better tests?

    Part of this problem is the ongoing and mistaken use of the term “screening” to mean testing of an individual. “Screening” is a term properly used to apply to the testing of all members of a defined group. Testing is something done for an individual.

  8. OK Mike — so screening only saves several thousand lives, or several hundred lives, or a few lives, or maybe just one life; however, unrefined the PSA test, it still saves lives.

    Now, from a public health policy point of view, we have to put a value on the life we are saving and compare that to the costs we are incurring, including the cost of overtreating men. Am I understanding correctly that the opinion of The “New” Prostate Cancer InfoLink is that the costs outweigh the benefits for widespread PSA testing? If so, many of us on your site are eager to see your calculations, especially those in late stage disease or about to lose a loved one!

    We all agree that better tests are needed, and frankly many are in the works; more pressure cannot hurt but this does not need to be our community focus. Several esteemed research hospitals are focused on genetic research and the Prostate Cancer Foundation channels millions into research annually.

    I, and evidently others, believe that we should unconditionally support PSA testing until we have something better — it saves lives. We acknowledge over-treatment is a side effect, but this arises from poor education and poor doctoring, namely the response to the information, NOT the information itself. Without widespread testing we will not save lives.

    Incidentally, PSA testing in Holland and Sweden has been available and used for many years — maybe not for everyone, but prevalent and used when needed as in the US. No question success rates may be higher if introduced to a community that has NEVER been tested; if it has been tested, then we save lives at a marginal rate, and what is wrong with that?

    We hope NPCI will reconsider its position, emerge from the dark shadow of the “Otis Brawley/ACS” viewpoint and start to advocate widespread PSA testing at the same time as supporting better tests.

  9. HIGH RELIABILITY NOW IN DETERMINING WHO NEEDS TREATMENT

    Hi Chris. I’m responding to your post at 3:14 pm, in which you included the statement: “… Unfortunately right now there is no way to determine the people who need treatment and the ones that don’t. So we err on the side of caution with almost everyone. Sure you can make an educated guess about some individuals and determine they need treatment, i.e., the more advanced cases….”

    Actually we DO NOW have a way of determining the need to treat that is highly reliable, though not quite perfect. That way is “active surveillance” (AS) for men who have low-risk case characteristics or a combination of other serious health concerns and acceptably low risks for prostate cancer. The wonderful development we are now enjoying is the fruit of long-term research on AS, which is showing that deferring (or never needing) therapy for appropriately low-risk men is virtually as effective as moving straight to therapy. Research from AS programs is converging on a success rate, meaning patients who do not need to move to therapy, of about 70%.

    That success rate is based on about three to six main standards for juding risk, such as the PSA level, Gleason score, whether a nodule can be felt, PSA velocity (more about that elsewhere — the context is key), the percent of biopsy cores that are positive, and PSA density. That 70% success rate can no doubt be boosted by adding other qualifiers, such as color Doppler ultrasound (CDU) or saturation biopsy results. Among other benefits, CDU adds key information about tumor vascularity, tumor shape, and tumor location for a substantial percentage of prostate cancers. The AS programs continue to refine their patient selection criteria and formulas.

    I’m impressed that this AS research involves some of the world’s most prominent prostate cancer centers and leading surgeons. Here are some of the ones many of us would recognize, including leaders: U. of Toronto, Sunnybrook (Dr. Laurence Klotz); Johns Hopkins (Dr. H. Ballentine Carter); Erasmus Medical Center (Dr. Fritz Schröder); Memorial Sloan Kettering (Dr. Peter Scardino); M. D. Anderson (Dr. Babaian); and the University of California, San Francisco (Dr. Peter Carroll).

    What all this means is that we NOW actually have quite reliable technology to separate those who need treatment soon from those who do not and who may never need treatment. Hopefully we can increase the reliability even further and can find an even better set of standards for assessing, but we are already doing well.

  10. Dear Rick:

    The “New ” Prostate Cancer InfoLink is not for one moment stating — and never has stated — that in our opinion this is about the cost of PSA testing. Simply because we agree with many others that there are insufficient data to support a national policy that every man should get a PSA test every year (or every 2 years, or whatever), beginning at some specific age yet to be determined with any degree of accuracy, does not mean that we wish to deny PSA testing to anyone who wants to be tested. Indeed, I am personally responsible for drafting the talking points subscribed to by all of America’s Prostate Cancer Organizations and issued in June 2009 which include the following statements:

    — “Every man has the right to know whether he is at risk for clinically significant prostate cancer that might lead to his death.”
    — “Regardless of his age, every man should discuss his individual risk for prostate cancer with his doctor (i.e., his primary care physician and/or his urologist), and request the appropriate use of PSA and DRE tests until better options are available.”

    The point that I am trying to make is the one that you all acknowledge and then ignore. We need a much better test. And we need that test badly. While we spend our time and most of our efforts arguing over the importance of the PSA test, we are missing the opportunity to advocate for more funds for research to find a better test. Genetic analysis is unlikely to get us this test because prostate cancer is a multi-step disease profoundly impacted by epigenetic issues. For every man with prostate cancer out there, what I am saying is that I don’t want your sons and your grandsons to have to make the same decisions you have had to make, based on highly interpretable information. I want to be able to tell them quickly that they need treatment or not — with a very high degree of accuracy — so that they can get on with their lives and not have to persuade themselves that they may or may not need a biopsy or that a half-cocked erection (for example) is worth the treatment that they can’t be certain they really needed.

    Others most certainly do frame this discussion in terms of economics. And economics have a role. But if we want a better test for prostate cancer, we all need to start to say so, loudly. We need the money for the research. We need the letters to Congress. We need pressure on the diagnostics companies that develop such tests. We need advocacy that will make it clear that we are not satisfied with the status quo. In the meantime, PSA testing is what we have. Those at significant risk should get tested. Those whose risk is unknown need to understand what th PSA test can (and can’t) tell them and make their own decisions about whether they want to get tested. But we still need a better test. Every minute that we waste not advocating loudly for a better test is a minute lost in making sure that test is available for your sons and your grandsons.

    Am I making myself clear now? By all means support what we have … but advocate for what we need!

  11. Dear Jim:

    I cannot agree with you when you say that active surveillance is a quite reliable means to “separate those who need treatment soon from those who do not and who may never need treatment.”

    Active surveillance (or any other forms of expectant management) is a risk management strategy. It is a means by which an individul patient and his doctor can try to make the best possible decision together about treatment or non-treatment based on the patient’s age, health, life expectancy, clinical characteristics, etc. But active surveillance does not and can not take account of fear of the unknown. People like Dr. Klotz and Dr. Carter — who have been at this for some time — will tell you over and again about patients on active surveillance who decided to be treated even though all the indicators were that they did not need treatment. Why did they makle those decisions? Because their fear that thay might have or get clinically significant and progressive disease outweighed all the data that said they didn’t and they wouldn’t. As far as I am concerned, this is just one more reason why we need a better and more accurate test which can discriminate between indolent and clinically significant prostate cancer.

    Do I think expectant managemebt is a good thing? Absolutely! I have been advocating for it in various forms since before I met Terry Herbert and shortly after I first met Gerry Chodak (in 1989). But we still need a better test!

    :O)

  12. From the time one cancer cell becomes two nobody knows if either one drifts off into some other place in your body. It will be nearly impossible to determine with any test if you have localized desease or not. Active surveillence should be called active gambling. You don’t know the extent of your cancer based on biopsy and/or any other current tests on the market. Even after radical prostatectomy, they can’t tell you exactly the extent of your cancer. I don’t know anyone who can slice a prostate into layers one cell thick and examine each layer.

    I think a lot of time and money is wasted on finding markers. We know for sure cancer exists and find it most of the time long enough before it kills. Wouldn’t most of this money and effort be better spent on trying to cure it. Finding a better test seems immaterial to me. We still have to deal with the afterwards.

  13. I’m all for finding better treatments too. Wouldn’t it be just great if we could tell you you did or you didn’t have potentially clinically significant disease with 95% accuracy at the time of diagnosis and that we could either (a) completely prevent its progression or (b) completely remove the cancer with 99.9% effectiveness and minimal side effects?

  14. FEAR AND BOLTING FROM ACTIVE SURVEILLANCE

    Sitemaster, I’m responding to your response of 8/18 at 5:50 PM in this lively discussion.

    Yes, fear certainly can give all of us cold feet from time to time, and it accounts for some decisions to abandon a successful experience with active surveillance. That has been studied. For instance, Dr. Klotz and team have commented on the psychological burden of men on AS and communicating to support their concerns, finding that the burden is quite tolerable for most.

    More to the point, the proportion of these terminations is not large, compared with the proportion of patients who stick with the program. Moreover, as studies continue to accumulate on the success of active surveillance long term, coupled with success for those men determined by active surveillance to need treatment, that fear is bound to decrease.

  15. Mike:

    It is somewhat gratuitous and misleading to say ‘The “New” Prostate Cancer InfoLink is not for one moment stating — and never has stated – that in our opinion this is about the cost of PSA testing.’

    Your initial post clearly states “we believe Bangma and his colleagues are correct, in the context of public health policy.” Bangma et al. list their opposition to widespread PSA testing based on:

    * A large increase in the cumulative incidence of prostate cancer
    * A significant cost associated with diagnosis and treatment of potentially indolent or at least not clinically significant disease
    * A significant impact on the quality of life of men who are arguably being “over-treated”

    These reasons are all founded in public health policy — thus it follows that The “New” Prostate Cancer InfoLink is stating that the cost of PSA testing , whether it be private, public, social or economic, does out weigh the benefits.

    That you support the right for every man to know his PSA is a far cry from advocating regular testing. It appears that The “New” Prostate Cancer InfoLink wants to have its cake and eat it too. You don’t support active regular PSA testing, yet you don’t want to be identified with those who are opposed to PSA testing. I do not believe you can have it both ways. Saying that

    — “Every man has the right to know whether he is at risk for clinically significant prostate cancer that might lead to his death.”
    –- “Regardless of his age, every man should discuss his individual risk for prostate cancer with his doctor (i.e., his primary care physician and/or his urologist), and request the appropriate use of PSA and DRE tests until better options are available.”

    is a far cry from recommending that doctors take the initiative and attempt to test men over a certain age.

    I have recently counseled two men in their 50s who were diagnosed with T4 metastasized prostate cancer throughout their body. Both asked me, “Why didn’t the doctor recommend testing?” Many of us advocates will not hide behind the statement that, “We did recommend that you know your PSA, even if your doctor didn’t suggest it!’. To me and to others who are now working to address this issue, that’s a cop out!

    Further, the reasoning behind the June 2009 statement you drafted is precisely because the all-inclusive costs, not just the economic cost, outweigh the benefits. Go tell that to the 55-year-old whose bones are riddled with cancer, or the 50-year-old widow whose husband just might have been saved through comprehensive PSA testing.

    Finally, we are not ignoring new research for better diagnostic testing. We fully support it, but this thread is an argument about actively supporting PSA testing; none of us deny better tests are required, and many of us support research in other ways. As Stan rightly says,”I can address two issues at the same time, and I bet you can too!”

    rd

    PS: You state “We agree with many others that there are insufficient data to support a national policy that every man should get a PSA test every year (or every 2 years, or whatever) …”

    Some of those who felt the data was insufficient have now publicly changed their view — like the not insignificant National Cancer Institute. Perhaps The “New” Prostate Cancer InfoLink might reconsider too.

  16. Dear Rick:

    I refer you to the statements about prostate cancer screening with PSA and DRE on the web site of the National Cancer Institute. These statements are entirely consistent with the position of The “New” Prostate Cancer InfoLink. Indeed, on the patient pages related to prostate cancer screening, one of the headings clearly reads (in bold type): “There is no standard or routine screening test for prostate cancer.” Please let me know where the National Cancer Institute has issued any statement advocating that every male should get regular testing for prostate cancer. Maybe I have missed something. If so I would like to know.

    I entirely understand that you disagree with our position. That’s fine, but a large part of the reason you appear to disagree with me is that you are not hearing what I am saying. The fact that we report the opinions of Bangma and his colleagues does not make those our opinions. Our only opinion about prostate cancer screening (as opposed to individual testing) is that there are insufficient clinical data to support a national recommendation that every man over a specific age should get tested. You have decided that we are making that decision on economic grounds. I can only advise you that this is not the case. In the Netherlands, where there is a government-funded health care system, Bangma and his colleagues apparently think economics are relevant. That is their opinion.

    We also happen to think that there is an obligation on primary care physicians to talk to their male patients about whether the patients want to receive a PSA test as part of their annual health check up. The obligation should most certainly not be entirely placed on the patient to request a PSA test. From that point of view we most certainly support access to PSA testing and patient education about the test. The place where we draw the line is exclusively about a national screening recommendation.

  17. I think the shoe is on the other foot, Mike.

    (1) You state you just “report the opinions of Bangma et al.” when you unequivocally state, “We believe Bangma and his colleagues are correct, in the context of public health policy.” That sounds to me like it is your opinion, not just “their opinion”! How else should readers interpret this, if not [by thinking that] The “New” Prostate Cancer InfoLink’s opinion is the same as Bangma’s opinion? Let’s not argue semantics. If you did not mean you believed Bangma was correct, then please tell us what you did mean.

    (2) Twice you have said I refer to economic grounds as the reason the PSA test is ineffective. Bangma and myself both refer to all costs; please read both my posts carefully. I repeatedly refer to all costs, not just the economic costs. Bangma et al., too, cite more than just economic costs.

    (3) I refer you to the statement released by NCI on 7/13 reported by ZERO here.

    (4) Please can you clarify for us what you believe the obligation of the PCP to be. Should PCPs speak to every man for whom “testing” is recommended by either ACS or AUA guidelines? Would you endorse HMOs like Kaiser sending mass mailings to encourage patients to have this discussion.

    (5) Can you tell us why The “New” Prostate Cancer InfoLink does not endorse national screening, since it definitely appears to save lives per NCI’s July 13 statement. Do you believe the TOTAL costs outweigh the total benefits?

    rd

  18. Dear Rick:

    (1) and (2) Dr. Bangma and his colleagues make the explicit statement that prostate cancer screening “cannot be justified yet in the context of a public health policy.” They give several reasons for their conclusion, just one of which refers to costs, as follows: “the understanding of the economic cost and quality-of-life parameters are limited.” You are choosing to use the term “costs” more broadly. This is a semantic issue. I am solely referring to Bangma’s statement about economic costs. I do not know what you mean by “all” costs. How are you defining those? Are you including the emotional costs of all those who deeply regret their decisions to have treatment after they have suffered from the consequences?

    (3) The statement you refer to on the ZERO web site does not actually reflect what the NCI said in its Bulletin issued on July 13 at all. I gently suggest you read the original. My good friends at ZERO are totally committed to PSA screening, and that interpretation of what the NCI stated on July 13 would make a political “spinmeister” proud!

    (4) I believe that every primary care physician should be responsible for initiating a conversation with every male patient at any reasonable opportunity about the pros and cons of PSA testing and that individual male’s potential risk factors. That is what both my last two PCPs have done, and very well too! I further believe that it would help if the primary care organizations issued some clear guidance to their membership about how to have that discussion in a balanced manner, and I think it would be an excellent idea if an organization like Kaiser included balanced information about the pros and cons of PSA testing in its patient mailings.

    (5) The reason that The “New” Prostate Cancer InfoLink does not and has never endorsed mass, population-based screening for prostate cancer is that there is no well-established evidence that it saves lives overall. Even the Goteborg study didn’t show that. It is one of the most important findings of the study. On the other hand, there is extensive evidence of over-treatment and the adverse effects of over-treatment of men with very early stage, low-risk, localized prostate cancer. What we absolutely do support is understanding of personal risk and the individual right of every man to make his own decision about whether he wants to be tested based on sound and unbiased information.

    I still don’t know what you mean when you ask whether I believe that the total costs outweigh the total benefits. What I can tell you is that I think in the USA today the overall benefits (of mass, population-based screening) do not outweigh the overall risks — a conclusion Tom Stamey, who was an acknowledged expert on the PSA test, also came to several years ago (to much abuse from his colleagues).

  19. Just another example of the ratcheting down of access to care. Seems pretty obvious that health care rationing will be operationalized as a public health model that centers on the abandonment of outliers. We’ll need to pay hyper-close attention to documenting family and personal health histories to establish risk factors in order to justify access to affordable, or any, care.

    The current policy movement in cancer (not just prostate, but breast, colon, lung — got to get everybody back to the < 1 year and out pancreatic model) treatment appears to be to ignore and delay diagnosis long enough to significantly limit the time and resources needed for treatment. If we refuse to diagnose cancers, either through public health screenings or full disclosure between individual doctors and patients, until they’re Stage IV, we haven’t had to waste all those dollars on the potentially curative and/or high manageable, but very expensive, stages that prolong life but eat into insurers’ profit margins.

    The good news is, most of us have a strong enough will to survive to make an upside down system work for us — know your family history, be aware of and freely report the symptoms of conditions that will “legitimize” you into a group that qualifies for early detection and screening.

    The not-very-subtle subtext of the post-reform talks about the cost of public health is that none of us as individuals live a life worth saving. They’ll pay for you to “battle” cancer for a year or two, then you better get better or you need to die, but they’re not interested in spending hundreds of thousands over a decade or two.

  20. HEALTH CARE REFORM IS ON OUR SIDE!

    Tracy, I believe your concerns may go away if you are able to look at the Patient Protection and Affordable Care Act (health care reform law) from other viewpoints. You wrote in part:

    ‘Just another example of the ratcheting down of access to care. Seems pretty obvious that health care rationing will be operationalized as a public health model that centers on the abandonment of outliers. We’ll need to pay hyper-close attention to documenting family and personal health histories to establish risk factors in order to justify access to affordable, or any, care. …

    ‘The not-very-subtle subtext of the post-reform talks about the cost of public health is that none of us as individuals live a life worth saving. They’ll pay for you to “battle” cancer for a year or two, then you better get better or you need to die, but they’re not interested in spending hundreds of thousands over a decade or two.’

    Having followed development of the law closely over the past two years through enactment, as well as statements by leading presidential candidates including President Obama, I see this so differently. Not the least of the education I got was the President’s story of his own mother’s having to fight the insurance company for coverage as she neared the end of her life; I found his account moving and motivating!

    Just for starters, the new law will be covering an additional 32 million people. However, we all look at how we will personally be affected, and the new law is effectively a Patient’s Bill of Rights with vitally important new protections for those of us who now have insurance, preventing and reversing erosion of its value in recent years.

    Some highlights from those rights include: coverage of children with pre-existing conditions now and in 2014 for adults; standard and few reasons for refusal to insure applicants; free preventive care of certain types (need to reverse the stand of the USPSTF so that prostate cancer testing will be covered); barring insurers from jetisoning insured patients when they begin to incur large expenses; elimination of lifetime limits on coverage; limits on our costs during catastophic periods; permitting unmarried children up to age 26 to be covered on their parents policies; help for early retirees; help for those affected by the Medicare “doughnut hole”‘ disclosure of nutritional content mandates; mandated minimums on the proportion of insurers’ incomes that must be spent on care (vice profit and overhead).

    How can you call that “ratcheting down access to care”? It profoundly is the reverse!

    Now let’s consider costs. I have excellent health insurance as a Federal Government retiree, benefiting the system on which the new law was loosely modeled, a law which passes on many of the wonderful benefits that I and my family have enjoyed for decades. It is not free; I pay my share of about $4,800 per year for the plan I chose, plus deductibles and out of pocket expenses.

    As just one key example, one of the great benefits of having good insurance is typically a mail service prescription plan. Recently we filled several prescriptions at our local drug store for convenience, and we were stunned by the cost difference! Right there, millions of Americans will now be able to save huge amounts of money filling prescriptions, taking advantage of the insurer’s ability to achieve mass efficiency and to bargain as a large customer with suppliers.

    Additionally, costs for care for the average prostate cancer patient are dropping sharply, I believe, and are poised to decline further. Savings are coming on multiple fronts, such as from plunging by two thirds or more as a substantial proportion of our key drugs (including expensive ones) go generic (examples: Casodex to bicalutamide; Zoladex, losing patent protection this year, and going generic as goserelin this year or next, also putting downward competitive pricing pressure on Lupron and other LHRH agonists; Fosamax to alendronate; Proscar to finasteride; and Zocor to simvastatin, the latter going generic a long time ago and really cheap now. Yes, Provenge is very expensive, but it is not meant for many of us, and on balance, considering the numbers of patients affected, the overall drug cost burden for prostate cancer patients as a group should be dropping sharply.

    Another favorable falling-cost area stems from the wonderful success of active surveillance programs for low-risk patients. It now appears that about 70% of such patients will not need treatment long-term or ever, with a huge net savings of treatment and care costs.

    Advances in knowledge of the lack of value of some formerly routinely used imaging for staging cancer are also saving huge sums. In 2009 the American Urological Association came out against routine use of bone and CT scans for staging patients based on the minimal worth of CT and bone scans for that purpose. The AUA described criteria for using those scans to focus on circumstances where they could add value.

    We are also learning a lot about prevention of prostate cancer through low-cost and mild drugs as well as through lifestyle tactics, such as nutrition/diet/supplements, exercise and stress reduction. Like active surveillance, prevention will cut down on the need for expensive therapies and care.

    It’s not about rationing; rather, it’s about avoiding unnecessary and excessively expensive care, and care to those who need it!

  21. Let me focus on your question in #5, Mike; as you will see by rereading Bangma, they go way beyond just economic costs. Here are some costs and benefits that we have to weigh before making the statement that overall benefits do not outweigh risks — or more broadly quantified costs from those risks; perhaps others on this list can add more costs and benefits!

    The costs:

    > economic & private costs
    – the financial cost of mass screening
    – A significant cost associated with diagnosis and treatment of potentially indolent or at least not clinically significant disease (from Bangma)
    – Economic value of lost lives eg cost of paying pensions/ life insurance early is just one example

    >social and public costs –
    -A large increase in the cumulative incidence of prostate cancer (from Bangma) … this of course is a direct result of more testing, not a cause!
    -A significant impact on the quality of life of men who are arguably being “over-treated” (Bangma)
    – Loss of life through the death of men whose cancer would have been caught at an earlier stage – eg cost of losing men whoa re contributing to the economic and social well being of society

    The Benefits:

    >Economic & Private
    – Lower treatment costs for men whose disease is caught at an earlier stage and require less healthcare.
    – Healthier men who continue to contribute to their families’ economic and social well-being

    >Social & Public Benefits
    – Lower death rate from PrCa and saved lives that have a value to the economy and society at large
    – Longer life expectancy for men diagnosed with prostate cancer at an earlier stage
    – Less resources devoted to PrCa healthcare from a healthier population and early diagnosis

    Evidently NPCI has considered these costs/risks and benefits and comes down on the side of rejecting mass screening since the costs/risks outweigh the benefits – your statement above.
    I, for one, am eager to see your calculations – or at least your reasoning to support your conclusion that “the overall benefits (of mass, population-based screening) do not outweigh the overall risks”. I should add that all these costs and benefits CAN be quantified – that is what epidemiologists and health economists do for a living; it is not easy, but it is feasible.

    rd

  22. APPALING LACK OF INSIGHT BY NCI RE SCREENING RESEARCH

    Hi Sitemaster,

    Thanks again for steering us toward key documents in the prostate cancer world, including NCI Bulletin, volume 7, number 14, issued July 13, 2010 (author: Carmen Phillips). You provided a link in your response to Rick of August 19, 2010 at 1:22 pm. Reading their bulletin is enough to make a grown man scream! (Here’s a suggested scream, borrowing from the film: “I’m mad as hell, and I’m not going to take it anymore!”)

    There are several serious deficiencies in the PLCO and ERSPC research, published in the New England Journal of Medicine last year, that challenged the value of prostate cancer testing, but premature follow-up had to be a critical deficiency. Yet the NCI Bulletin seems totally ignorant of this. Here’s part of a pertinent paragraph from the Bulletin:

    “In an accompanying editorial in Lancet Oncology, Dr. David Neal of the University of Cambridge in the United Kingdom sorted through some of the key differences that could have led to these results, including the Göteborg trial’s much smaller size (20,000 men compared with 77,000 in PLCO and 182,000 in ERSPC), different screening schedules, and longer follow-up (14 years compared with 11 and 9 years, respectively)….” There is no other insightful discussion of the follow-up for PLCO and ERSPC.

    Note those “follow-up” figures of 11 and 9 years for the ERSPC and PLCO trials. On the surface, they appear only mildly premature, in view of the 99.6% survival of white men in the US in the period 1996-2004 at 5 years (128th Statistical Abstract of the United States 2009) and 95% survival of high-risk prostate cancer patients at the 10-year mark (Mayo Clinic, J Urol, April 2008).

    However, these survival statistics count survival from time of treatment, while the screening studies count it from time of enrollment in the screening studies. Obviously it is not obvious to the NCI (or the researchers) that there is a substantial typical gap between study entry and diagnosis with prostate cancer. I saw a figure on that once, but my impression is that the gap was about 4 years (help here?). When you subtract that gap from the published follow-up of 11 and 9 years, you get a survival follow-up after treatment of about 5-6 years. Is it any wonder that the benefits of screening would not show up with such extremely short follow-up? I’m thinking the 20% survival advantage that did turn up in the ERSPC study (now arguably increased to 31% based on post hoc analysis) was due to the inferior screening program in the study, which included tests every 4 years as I recall it.

    I’m feeling like Casandra here — the mythical, frustrated prophet who could see the future but was unable to tell anyone about it. I know that a number of us have been trying to call attention to the critical lead-time problem with the PLCO and ERSPC trials, including some prominent leaders. I mentioned the lead-time issues and a couple of other major study flaws to Dr. Otis Brawley in the moments before a Congressional hearing on screening and thought from his response to me that he saw things the same way, but his testimony reflected no grasp of its significance.

    Why can’t cancer leaders see this? I truly am at a loss to understand why folks like the NCI, the ACS, the editors/reviewers of the New England Journal of Medicine (who at least mentioned the issue in an editorial, building on passing mentions in the discussion sections of the papers themselves), the US Preventive Services Task Force, and, surprisingly, the National Comprehensive Cancer Network are unable to achieve insight into the leadtime issue. (Oh yes, I forgot: the USPSTF has no board members with any expertise treating prostate cancer patients.!)

  23. Since this article from 2009, diagnosis has moved on to mpMRI. Some urologists are confident enough using PSA, free PSA, digital exam, and mpMRI to not progress to biopsy; and if so exclusively by transperineal template biopsy to reduce the risk of sepsis and provide better positional diagnosis of aggressive cancers. A patient might have other non life-threatening urological conditions but if not patients are referred back to the GP and possible ongoing monitoring.

  24. Dear Mr. Buckle:

    The availability of MRI scans still doesn’t change the argument made by many that “screening” for risk of prostate cancer (carried out using PSA testing) is still not justified for all sorts of reasons. We are still in the process of learning how to determine who needs to be tested on a regular (annual) basis (“screened”); who needs to be tested — say — every 5 years or so; who needs to have a biopsy; who can safely be monitored as opposed to treated; etc. And the role of mpMRI scanning in all of this is evolving as I write. There are no definitive and absolute guidelines around any of this yet because so much depends on the individual characteristics exhibited by the individual patient.

  25. Hello Sitemaster,

    There never will be definitive and absolute guidelines. Medicine is rarely an exact science, as with most aspects of life. However, I really do take issue with people that demean (trash) the various PSA tests available. This is completely the wrong message to men and some GPs. PSA is very accurate and useful; the follow-on tests and interventions are where the issues lie. I know one UK hospital where sepsis from biopsies, and over-treatment, are down to extremely acceptable risk/benefit levels. For instance, all biopsies are transperineal, never rectal. There are excellent urologists that are comfortable with these decisions you mention and plan treatment or monitoring individually for each patient: “who needs to be tested on a regular (annual) basis (“screened”); who needs to be tested — say — every 5 years or so; who needs to have a biopsy; who can safely be monitored as opposed to treated;”

    The PSA test is here to stay, targeted screening using PSA in conjunction with other diagnostic tools is overdue in the UK. Men are being disadvantaged. 12,000 deaths per year and 330,000 men living with the disease is a medical failure and a national disgrace:for a disease that can usually be caught before metastasis.

  26. Dear Mr. Buckle:

    I don’t know who you think is demeaning (trashing) the PSA test. The PSA test has considerable utility. However, it’s value does not lie in annual mass testing (true “screening”) of the PSA levels of every man over 50 years of age. This is now extremely clear.

    I would also point out to you that when free PSA testing was offered to several hundred thousand men in the UK in the CAP trial — as a part of the process of identifying men to participate in the ProtecT trial just a few years ago, the vast majority of the men (74%) to whom it was offered never went to get such a test. See here for the details. That is a definitive set of data on why (for most men) PSA screening is ineffective and inefficient.

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