New, six-point statement about PSA testing issued at PCWC


According to a report on the Bloomberg.com web site, attendees meeting at the Prostate Cancer World Congress (PCWC) in Melbourne, Australia have issued a new, six-point consensus statement about the use of the PSA test in the initial detection of prostate cancer.

The key points of the consensus statement are as follows:

  • For men aged 50–69, there is evidence that PSA testing reduces the risk of metastatic prostate cancer and of death from prostate cancer by up to 30 percent and 21 percent, respectively.
  • Prostate cancer diagnosis must be uncoupled from prostate cancer intervention through active surveillance of men with low-volume, low-risk prostate cancer.
  • PSA testing should not be considered on its own but as part of a multivariable approach, including digital rectal examination, prostate volume, family history, ethnicity, and risk prediction models.
  • Baseline PSA testing for men in their 40s is useful for predicting the future risk of prostate cancer, especially for those whose baseline PSA is in the highest centiles above the median.
  • Older men in good health with a life expectancy of more than 10 years should not be denied PSA testing on the basis of their age because a small proportion of older men may benefit from an early diagnosis of more aggressive forms of localized prostate cancer.

The “New” Prostate Cancer InfoLink concurs completely with this six-point statement. The critical issue will be whether the global urology community actually starts to act in accordance with these six points and proactively starts to help patients with clinically insignificant prostate cancer to avoid over-treatment and its consequences.

16 Responses

  1. I have several problems with this statement. First, to quote the relative improvement in mortality without also providing the absolute improvement overstates the value of testing. Second, recommending testing starting at age 40 will undoubtedly lead to further over-testing and over-treatment because many men will end up with a biopsy and face the dilemma of having small volume disease at a young age for which active surveillance will be unacceptable. Their last statement about older men should not be denied testing should also include a statement about the even smaller odds of benefiting given the results of the PIVOT trial and Swedish trial for men over 65. Lastly, they should have included a statement about repeating the PSA when changes occur given the 20-30% chance it will decline with another test.

  2. Gerry:

    All the points you make are good ones. In a “blown out” version of this six-point consensus statement, I would agree that they all need to be emphasized.

  3. Next step would be to have a similar statement published by the Prostate Cancer Roundtable?

  4. Wolfram: I have already made the members of the Roundtable aware of this new statement.

  5. Until the ability to distinguish indolent/low-risk “cancer” from high-risk cancer is achieved, active surveillance (AS) has to be acceptable for “young” men. And there are most certainly urologists currently using AS protocols with men under 55 years of age and/or with a life-expectancy of greater than 10 years, as well they should be. It’s way, way, way past time to quit maiming men unnecessarily.

  6. There is urgent need to avoid over-treatment,but where is the urgent need to avoid death from prostate cancer. Why aren’t the AUA experts promoting an acceptable, consensus (with its limitations) AS protocol?

    It is obvious that this notable list of experts at the Prostate Cancer World Conference do not agree on the limiting age restrictions of the AUA’s recent PSA testing guidelines. Given the known uncertainty of the current diagnostic tools, this prudent and logical statement from these experts needs some work to avoid both over-treatment and deaths. It can be done!

  7. I am frankly getting annoyed by constant references to “over-treatment” as an excuse to disparage the utility of the PSA test. If there has been over-treatment, i.e., unnecessary treatment, this is not the fault of the test. It means someone made a poor decision on how to respond the the test result. It is a poor workman who blames his tools. Deciding what to do with a test result obviously has to take various factors into account: family history, previous test results, biopsy findings, age and health of the patient, etc.

    My PSA result, in 2004, was just 5.1 but it had jumped from 4.0 four months earlier. My older brother had died of prostate cancer, so I was obviously at greater risk. Ultrasound exams were done and increased the suspicions. Biopsy then revealed a Gleason 9 cancer. Fortunately no evidence of metastasis was found. I was treated (external radiation plus hormonal therapy) and, 9 years later, my PSA is still low and steady (around 0.2) and I feel fine for an 84-year-old.

  8. What will change? Very little in my view. I am still amazed by some of the stories I read on my site and in correspondence.

    Today’s includes a beauty that the urologist concerned, in the face of a negative DRE and biopsy, told the man they had never had a patient with a PSA of 4.8 ng/ml who didn’t have prostate cancer!

    Yesterday a man with a single positive biopsy core of Gleason score 3 + 3 = 6 and a PSA of 7.00 ng/ml was told surgery was required — unless he went the ADT route with IMRT suggested by his second opinion (an oncologist yet).

    It’s all rather depressing, I find.

  9. Dear readers,

    Ann-y-mous has been staying quiet reading the postings; ’tis time to squeak again.

    The re-naming of cancer recently, to me, indicates that patients will still be treated under a new heading. A new cutting tool is on the horizon, but seeing different smoke indicates cancerous vs healthy tissue. … Too bad the healthy gets cut also. We are getting closer, hopefully, as time progresses — and hopefully the prostate will not become totally useless, but will still have some of it’s old capabilities … hope for a full life.

    The conference concerning AS was interesting to read about. Too bad that that card was not even put on the table or presented to me. My PSAs were done at different labs, but the profession discounted that factor and did not recommend that another PSA be drawn and sent to their lab again. They just viewed the absolute numbers. ‘Twas interesting to review the numbers and see that higher numbers came from facilities that were active in treating cancer. None stopped to look at and listen to me, the patient. I felt like the PSA was the ticket and it was punched for the total trip.

    I had the biopsy and was refused a second opionion or allowed the time to pass before obtaining a second “correct” biopsy. The train must stay on schedule … or as one doctor told me, “If I do not feed the system, they will replace me with one who will.”

    I decided to do the radiation, so that I could continue working. My PSA dropped in 3 months – to half the originalvalue — and doubling it indicated that I was under he old panic value of 4.0. Next week, I go for the second post-treatment blood test … literature indicates that it should be three-quarters of the pre-treatment value. Quality of life, excuse me for I have a running nose, but am able to work/shop without knowing where the bathrooms are. It was brought to my attention at a meeeting, that it will take 3 years to become the new 20% less than the old normal.

    Now about the posting … As I have read, one can find cancerous cells in 60-year-olds … fact of life. True there are qualifiers with a predisposition, but in my case, none applied (family, race, living conditions, etc.), just a normal guy who happened to have a PSA of 4.0 from a visit and a new lab reporting the test results.

    The guidelines have been dropped (down to 2.0-2.5 ng/ml and age of testing down to 50, so now — with newer techniques and a larger population to draw from — the number of new cases will be higher. The ticket has been punched and the machinery/pressure is set in motion. A recent posting indicates that even if a doctor does sit down and take the time to talk to his patient, which is a rarity, the pressure is on to decide which of the two treatments are decided on. AS is, I assume, not presented as an option. (Again, we are talking about the “normal” gentlemen outside of the “risk” category.)

    I will agree that, within the age span mentioned, PSA testing does catch cancer and, with treatment, does lower the number of patients dying … but they will die from other factors sooner or later. Previous posts discussed this. The lowering of the age to begin testing — originally 50; now 40 in order to get a baseline — does feed into the system a high number of patients and a greater number whose life will be drastically changed. True, if educated or not via the dotcor or literature, some will opt to get it out now and not fully understand the consequences … posting on this issue.

    In the old terminology of low risk, AS should be put on the table as a viable option. It buys time to track the PSA using data from a single lab and allows men to find out that they are not at the end of their life but are montioring things — just like triglycerides, cholesterol levels, etc.

    For me, it seems, the PSA value became the sole issue. Very little concern was placed on the other risk factors. My father is 97, so mentally I am looking at another 30 years of ticking. True, car accidents do occur, but as the first contact about prostate cancer said, you will [likely] die with prostate cancer, not from it, due to the lowness and other “risk” factors.

    I was given low percentage figures, but also told that since I have them I must have prostate cancer, therefore action must be taken!! So, to me, the percentages of volume, mass, DRE just feed the fire and were not to be viewed from a distance to see the “big” picture.

    As for older men with “longer life expectency” … test them. But the PSA won’t tell if the cancer is aggressive or not,, a biopsy will. … There was a post about something coming down the line that may mean that such an invasive test(the biopsy) may not be needed. … Soon ? But again, after the biopsy, the pressure keeps being applied, for we have built the machine and “we must use it continuously thinking” comes into play.

    As for AS, it may be a way to delay things and therefore useful. It buys time, maybe a lifetime for a, now, 40-year-old. We patients realize and see the benefits from AS, for once the decision to treat is made, life is changed for 10, 20, or 30+ ears. … Think back on your own life for that period of time.

    True, early testing will catch the (old nomenclature) middle- and high-risk patients and give them the years, and hopefully not see the end chapter of the book, painful as it is to read.

    Finally, for a doctor to recommend AS and sit down and educate the patient, so that the patient does not run to the hills to “avoid the water spilled from the galss onto the floor,” fearing a flood is coming, means that the doctor is “losing” a monetary amount. Once the patient starts down the road, the money is being drained from the patient. Until there is a test out there to differentiate aggressive vs. non-aggressive disease and just be viewing the different lab PSA results under a consistent system, like there is for triglycerides and cholesterol levels, then there is not a lot of motivation to reel in the maiming, for the doctors have a financial stake and now that the panic level and age (50 or now 40) is stated, there is a huge amount of potential money to be made and machinery to be kept busy. As in Seattle, a new [machine] is built, long hours sold and — like a donut ring — affects the area needs to expand to feed the new machine, regardless of the patient’s life.

    Well, this mouse has roared enough, so I will settle back and hope that within 10 years when my son becomes of age for the first testing, his doctors will not view me as the panic cause for action, the first and only in my family tree, but will monitor him instead of driving him to make a drastic decision that will harm his 30, 40, or 50 years of life. I have worn the Depends and do not look forward to wearing them starting in the next 4-5 years for the rest of my (say) 25 or 30+ years of life.

    Let’s end the pressure on the low-end bracket of viable young men, step back and just because the per-centages, any value, mean the the next rung in the ladder must be taken. As for me, the pressure is there to be at 0.002 within a year “or else” Come one now … let’s just monitor this thing. Because of the different labs utilized between urologist, radiation oncologist and primary care doctor, there is going to be a spike and bouncing around.

    Thank you for your patience.

    My doctor in the post visit wrote = wants me to continue seeing her specialist.

  10. I strongly disagree with Dr. Chodak’s conclusion that “recommending testing starting at age 40 will undoubtedly lead to further over-testing and over-treatment”.

    Dr. Chodak needs to make a distinction for men in their 40s between regular testing and seeking a baseline; these guidelines are clear in referring to “baseline.” Moreover there are epidemiological studies suggesting that men with high PSAs in their 40s are at high risk.

    For men with low PSAs, in their 40s, a good practitioner will not recommend repeat testing for some period, say 5 years. For those with high PSAs, they will be monitored and action may follow — and perhaps, Dr. Chodak, we will save lives.

    If over-testing and treatment does result, it is the fault of the practitioner not the test — testing is not treatment.

    Statements and conclusions such as those made by reputable and respected practitioners like Dr. Chodak do not help the cause to reduce mortality in younger men. As an active patient advocate, there is nothing that upsets me more than the man in his 40s with asymptomatic metastatic disease.

    How, Dr. Chodak, do you recommend we address this sub-population at great risk for early and painful death? Wait until they are 50, symptomatic and dying?

    rd

  11. Dear Rick:

    In defense of Dr. Chodak (who certainly doesn’t need my help, but is going to get it anyway), over-testing and over-treatment does not result exclusively from the behavior of overly aggressive surgeons and radiation oncologists. It also occurs when patients insist on treatment that may well be unwise, unnecessary, and against their doctors’ advice … and worse still when their relatives talk them into it. You may not like me saying this, but it happens all the time because of the “I’ve got cancer; just cut it outta there” syndrome.

    Neither you, nor I, nor Dr. Chodak want to miss the appropriate diagnosis and treatment of any 40-year-old patient with high-risk prostate cancer (whether it is micrometastatic or not). On the other hand, how many 40-year-old men with low-risk disease do you want to see having treatment that is not justified, despite the fact that you, I, and Dr. Chodak would all tell them they don’t need a biopsy or even — after a biopsy — that they don’t need the treatment because they could be actively monitored over time and get effective treatment if and when they ever actually need it?

    This is not a black and white issue. There are certainly men in their 40s who absolutely should have a baseline PSA (because of a variety of recognized risk factors); there are men in their 40s who may well benefit from having a baseline PSA so long as they recognize exactly what they are doing; and then there are men in their 40s who are probably going to be at massive risk of over-treatment if they go and have a baseline PSA because they don’t understand the potential implications at all.

  12. I accept it is often a patient decision, but I also believe that all too often, as reported in many forums, it is the medical team pushing treatment. Moreover, I have a very simple response, Mike … if you don’t test 40+-year-old men for a baseline, how will you ever know they are high risk until they are symptomatic … or, if fortunate, over 50?

    I would test as many men as it takes! All medical team members and advocates must inform men in no uncertain terms that low-risk disease does not require treatment, and if they still decide they want to be treated, have them sign a waiver or acknowledgement that they are aware of the incidence of co-morbidities.
    We cannot stand by and allow younger men to suffer high-risk disease and its consequences based on the argument of over-treatment; it is inhumane and counter to the Hippocratic oath if we have a simple way to save them … period paragraph.

    I agree that Dr. Chodak does not need an assist, but his position on testing is wanting — and we have discussed the same with Us TOO based on his writings in their news sheet. We have still to hear from him how he plans to address the incidence of high-risk disease in men under 50. I would be curious to know — and maybe you have those stats — how many men who die of prostate cancer were first diagnosed in their 40s?

  13. Rick:

    I understand your position but I just don’t think it is as simple as you would like it to be.

    With regard to the numbers … I don’t think anyone knows accurately what percentage of men diagnosed in their 40s actually go on to die of prostate cancer. What I do know is that the proportion of all men diagnosed with prostate cancer who are diagnosed in their 40s in the USA is < 3% and that about 15% those men are diagnosed with non-localized disease. We can reasonably suppose that those 15% (something like 950 men) have a high risk of dying of prostate cancer at some time in the future.

    The other way to look at this is to say that of 3% of the 220,000 men who are diagnosed each year are diagnosed in the 40s and that 25,000 men die of prostate cancer each year, then about 6,600 men are diagnosed each year in their 40s and that about 750 of those men may well go on to die of prostate cancer. One would be giving a baseline PSE test to millions of men every year to identify those 750, and even if one did try to do that, there is a high probability that many of those men would never show up to get tested anyway.

    Your intent is admirable. The reality of PSA testing is very different. The test just isn't that accurate, and many men who get aggressive prostate cancer in their 40s have low PSA values that would not necessarily imply the need for a biopsy.

    If either I or Dr. Chodak had a sensible recommendation as to how one could accurately assess risk for prostate cancer among men in their 40s without placing millions of men at risk for over-diagnosis and over-treatment, we wouldn't be having this discussion. Conversely, I don't think that forcing every man in America to have a baseline PSA when he is between the ages of 40 and 45 years of age is a very good idea. Give him the option, by all means. Tell him it would be wise if he is at high risk because of ethnicity and other factors by all means too. But you need to appreciate that as a culture we are absolutely not ready to embrace monitoring as a first-line management for low-risk prostate cancer yet (however much you and I and Dr. Chodak may think it would be a good idea).

  14. Mike,

    Do you have stats on all of this over-treatment that’s going on?

  15. Dear Jerry:

    There are all sorts of estimates about the amount of over-treatment but very few really accurate data. So, for example, it is estimated that some 25 to 40 percent of all the men getting treated for prostate cancer today here in the USA would probably do just as well on some form of careful monitoring as opposed to receiving immediate, invasive first-line treatment. (Obviously, that is not the case for men like you who clearly had clinically significant prostate cancer from Day 1!)

    There is no way for us to have accurate statistics until we have some data from really large clinical trials that include some form of active monitoring as a treatment option compared to surgery or radiation therapy. The first such trial to report such data will be the ProtecT trial, which is currently being carried out in the UK, and which might report some data by about 2015.

    In the meantime we have data from studies like the PIVOT trial and a large Scandinavian trial that have clearly shown that older men with low- and intermediate-risk prostate cancer appear to gain no benefit from surgery (as compared to “observation”) at 12 to 15 years of follow-up. In other words, treatment did not improve their overall survival or their prostate cancer-specific survival during the median follow-up period.

    We also have data from some of the larger active surveillance cohorts (like those of Klotz et al. in Canada) showing that < 1% of the patients in their cohorts of men with low-risk disease actually progress to having metastasis or prostate cancer-specific death. And we have data showing that men with true pathological Gleason 6 disease almost never progress to having either metastasis or prostate cacner-specific mortality.

    Regrettably, however, what we can not do yet is use such data to be able to project with accuracy what is going to happen over time to a specific individual who is diagnosed today with low-risk disease. We can tell him that he is very unlikely to become metastatic or die from prostate cancer within 15 years or so, but we can’t tell him with certainty that it won’t happen. Why? Because the tests we use today simply aren’t sufficiently specific. When a man has a biopsy that shows a single core of Gleason 6 disease in which only 1% of that core is positive for cancer, you need to remember that we have probably only biopsied about 0.25% of all the tissue in an average-sized prostate. Who’s to say that 5 mm away we didn’t “miss” an area of Gleason 4 + 3 = 7?

  16. Thanks Mike. Great info.

    There was a lot of Gleason 9 very close to a bunch of Gleason 6 for me. …

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