The new AUA guidance on PSA testing: a critical analysis


So now that the stream of data from the American Urology Association annual meeting appears to have run its course, we thought this might be an opportune moment to look very carefully at the new “best practice statement” on PSA testing issued at the meeting, with a particular focus on the use of PSA testing in assessing risk and the need for a prostate biopsy. The complete document is available on the AUA web site.

The first point that we would make is that the new best practice statement does not say what the media is already suggesting it says. As an example, the heading of an article on Medscape, issued on Tuesday, April 28, states, “PSA Screening Should Be Offered Beginning at Age 40.” Luckily, however, in this particular case, the article went on to more correctly state, in its opening paragraph, that, “The new guidelines have lowered the age for beginning prostate-specific antigen (PSA) screening to 40 years for relatively healthy well-informed men who want to be tested.” [Bold italics added for emphasis.] There is a critical and obvious difference between these two quotations.

In presenting the new guidance at the AUA’s annual meeting, Dr. Peter Carroll, the chairman of the committee that rewrote this best practice statement, made an absolutely crucial comment which is fundamental to the entire evaluation of the new document. He said,

The single most important message of this statement is that prostate cancer testing is an individual decision that patients of any age should make in conjunction with their physicians and urologists.

This statement reflects in part the following quotation from section 8 of the best practice statement on use of PSA in the early detection of prostate cancer:

Decisions regarding early detection of prostate cancer should be individualized, and benefits and consequences should be discussed with the patient before PSA testing occurs. Not all men are appropriate candidates for screening efforts for this disease. Ideally, physicians should consider a number of factors, including patient age and comorbidity, as well as preferences for the relevant potential outcomes. Screening in men with less than a 10-year life expectancy, either due to age or comorbidity, is discouraged.

So let us see if we can boil the AUA’s best practice statement down to its core. Here is what the AUA actually states. This is not an “interpretation.” We have used the AUA’s actual words:

  • “[I]t is still not clear that prostate cancer screening results in more benefit than harm.”
  • “The AUA is recommending PSA screening, as proposed in this document, for well-informed men who wish to pursue early diagnosis.” [The italic type is included for emphasis in the actual AUA best practice statement.]
  • “The goal of early detection is to reduce the overall morbidity and mortality of prostate cancer.” (In other words, the goal of early detection is not to find every single man who may have some cancerous cells in his prostate. Early detection is about identifying those men who are at risk for clinically significant disease as early as possible.)
  • “The proportion of clinically significant prostate cancer detected with PSA is unknown.” (In other words, we cannot rely on the PSA test alone to tell us which men have clinically significant disease and which men do not.)
  • “Men who wish to be screened for prostate cancer should have both a PSA test and a DRE.” (This has been the standard of care for initial assessment of potential risk for prostate cancer since the PSA test was introduced as a means to detect risk, and remains the standard today.)
  • “Although testing for PSA involves only a blood test, several subsequent events must be considered before the test can be considered innocuous. A positive test result affects patients both mentally and physically even if a patient chooses not to proceed to prostate biopsy.” (This is a critical statement. Fear of cancer is not necessarily rationale, and it can drive behaviors that are not necessarily in the best interests of the patient.)
  • “[W]hen added to total PSA, PSAV was not shown to be a useful independent predictor of positive biopsy.” (In other words, there is no proof whatsoever that PSA velocity can accurately predict risk for a positive biopsy any better than a single PSA value at a point in time.)
  • “The decision to use PSA for the early detection of prostate cancer should be individualized.” (In other words, the AUA is no longer making any blanket statement about testing of all men. They are saying that every situation has to be considered on its possible risks and its possible benefits.)
  • “Among men in their 40s and 50s, a baseline PSA value above the median value for age is a stronger predictor of future risk than family history or race.” (The best practice statement goes on to indicate that the median PSA value of men in their 40s is 0.6 to 0.7 ng/ml.)

Now the statements above have been extracted with great care from nearly 30 pages of text in the actual AUA document. The details of that document are extensive. And the devil, naturally, is in those details.

The “New” Prostate Cancer InfoLink believes that the new best practices statement issued by the AUA — when taken and applied as a whole — is a far better document than anything that has existed before as guidance for physicians (and their well-informed patients) on the pros and cons of PSA in testing of individual patients for prostate cancer.

We endorse this document wholeheartedly. However, we feel obliged to express a very real concern that many physicians will never actually read this document in detail nor will they act on its actual recommendation (as opposed to its perceived recommendations).

We believe that there is a very serious risk that this document will be wrongly understood to imply that the AUA has said that every man should get a baseline PSA test at age 40. The best practices statement clearly does not state this, however.

We call upon the AUA to make every effort to ensure that this is not the message received by the medical community or the public. We also call upon the AUA to ensure that its member physicians are fully informed about the guidance provided in this document, and act in accordance with this guidance.

In this context, we believe that we should also point out a problem with the patient brochure that was issued by the AUA Foundation at the same time as the actual AUA best practice statement. The AUA Foundation’s patient brochure states that:

Change in PSA levels over time known as PSA velocity is used to assess both cancer risk and aggressiveness.

We recognize that this statement is true. PSA velocity has been widely used in this way. However, this statement is in complete conflict with the statement quoted in bullet point 7 above and which appears on p. 19 of the AUA best practice statement. The use of PSA velocity as a means to predict the likelihood of a positive biopsy is not, in fact, substantiated by the available data, even though many physicians have been doing this for years. The AUA’s best practices statement has been clear in saying this, and the AUA Foundation’s patient brochure should reflect that reality.

7 Responses

  1. Mike,

    Your last paragraph is totally on point. Yet again, the prostate cancer medical community does not seem to be able to act appropriately on known information. PSA velocity — good grief! Will next year’s best practices key on free PSA perhaps, or maybe doubling time? After recent long-term study results regarding PSA screening …

    Given how the new guidance is likely to be misinterpreted, the likely result will just be more younger men diagnosed with smaller prostate cancers that mainstream treatment will often “cure” but with substantial morbidity. The ~50 to 80 number for men undergoing mainstream treatment for each man saved will likely go up, while the overall death rate may go down in the distant future.

    One can only hope that the new emphasis on “individual decision” will make a difference, and that men will be more appropriately counseled.

  2. Mike,

    I am not sure that the AUA Foundation statement is completely off point.

    In the AUA statement they say, “The current policy no longer recommends a single, threshold value of PSA which should prompt prostate biopsy. Rather, the decision to proceed to prostate biopsy should be based primarily on PSA and DRE results, but should take into account multiple factors including free and total PSA, patient age, PSA velocity, PSA density, family history, ethnicity, prior biopsy history and comorbidities” (see page 4). Isn’t it a valuable tool to be used as part of a decision making process?

    Another statement that I found interesting was a more complete statement from your quote above, “Because there is now evidence from a randomized, controlled trial regarding a mortality decrease associated with PSA screening, the AUA is recommending PSA screening, as proposed in this document, for well-informed men who wish to pursue early diagnosis.” This is the first time I have seen an early detection advantage stated. In the past it had been an assumed advantage.

    It was also interesting in their chart Figure 1: Early Detection they say “Counsel patient regarding both risks and benefits of biopsy”. I am not sure how many men are being counseled at this stage. This is a very good thing.

  3. Dear Kathy: The fundamental issue in all of this is that the AUA best practices document recommends individualized testing with PSA and DRE only for “well-informed” men (their words, not mine). Would you care to give me a percentage for the number of previously untested men who you think might be “well informed?” My guess would be an upper maximum of about 1 percent, and I suspect that that is an optimistic estimate!

    I don’t believe that the AUA Foundation’s brochure will make people “well informed.” To do that we need to start from an acceptance of the fact that 5 of 6 men (83.3 percent) will never have signs or symptoms of clinically significant prostate cancer (whether cancer cells exist in their prostates or not) and therefore don’t actually need to be tested. On a statistical basis, this means that your risk of having clinically significant prostate cancer if you do not get tested for it is five times lower than your chance of being diagnosed with prostate cancer (even if it is indolent) if you do get tested (and it may be less than that now that we have accepted that many men with indolent disease may suffer more harm than benefit from diagnosis and treatment). Sadly, in my opinion, the AUA Foundation document does not specify that men should be “well informed” before they can be expected to make a good decision.

    Again, let me quote the absolutely excellent opening statement of section 1 on page 10 of the AUA guidance: “The goal of early detection is to reduce the overall morbidity and mortality of prostate cancer.” To do that, we need to eliminate all morbidity (and the very rare mortality) associated with over-diagnosis and over-treatment in addition to the morbidity and mortality associated with clinically significant disease!

    With respect to counseling and biopsies, everyone except the AUA has been saying patients should be “counseled” about the risks and benefits of a biopsy for a decade. Saying it won’t make it happen.

    Until we know for sure that men are getting sound, customized, and neutral counseling about prostate cancer risk assessment, my fear is that the AUA best practices statement — which is an excellent document and does get into all of the details — will be diluted down to the idea that everyone should get a PSA test at age 40 because of patient brochures like the one issued by the AUA Foundation, which is still heavily slanted in favor of the idea of PSA testing. The PSA test is a wonderful test for monitoring some (but by no means all) of the effects of treatment. As a test (with or without a concomitant DRE) to determine the need for an individual patient to undergo biopsy, however, it is still a lousy test, and men absolutely need and deserve to know that.

  4. Mike,

    I am not sure why you think the AUAF brochure does not summarize the AUA full recommendation.

    They say: “The decision to use PSA for the early detection of prostate cancer should be individualized. Men should be informed of the known risks and the potential benefits of early screening. Not all men are appropriate candidates for screening efforts for this disease. Screening in men with less than a 10-year life expectancy, either due to age or other illness or disease, is discouraged.”

    There are risks but there are also benefits.

    They also say: “Early detection and risk assessment of prostate cancer should be offered to men 40 years of age or older who wish to be screened.” Knowing a man’s baseline PSA values in his 40s to compare with future PSA tests could help identify those men with life-threatening prostate cancer at a time when there are many treatment options and cure is possible.

    What I see is that they are saying the discussion should begin at 40 rather than 50 for men.

    If doctors are encouraged to use the information beginning on page 18 of the AUA document more appropriate biopsies will be done. In the past part of the problem has been the fact that a single PSA has been used as the trigger for a biopsy. That’s a good thing.

    How do you translate the information into a document that is understandable by someone with and 8th grade education? The primary care physicians must be educated. Men should be told to begin discussing prostate cancer with their doctors at age 40 according to the AUA document. Isn’t this what the AUAF document is saying? The balance is difficult. How do you say the positive things about early detection without appearing to encourage tests if someone has a bias against testing or say the negative things without discouraging the men who should be tested and appear to be saying all men should be tested at 40.

    I think that the AUAF is attempting to have that balance.

  5. Dear Kathy:

    I am not for one moment suggesting this is an easy equation. And I am also not saying that the AUA Foundation is a “bad document.”

    What I am saying is that we are still beginning from a point of view that suggests that “all men need to be tested” for prostate cancer (potentially at age 40 instead of 50) even though the tests we have are not discriminatory. I have always had a very difficult time with this viewpoint because of all the over-diagnosis and over-treatment. I would buy into this viewpoint very quickly if (and hopefully when) we had a blood or urine test that could assess risk for clinically significant prostate cancer with much greater selectivity and specificity. But we don’t.

    I believe that the AUA’s new guidance document — if accurately presented to people and accurately used — would help people to make better decisions about their need to be tested and how to interpret the results of such tests. However, you are absolutely correct. We live in a nation with an appallingly low standard of acceptable education and literacy, and it is not going to be possible to boil guidance that took 30 pages to write down for specialists in urology to a trifold brochure and pretend that if he has read the trifold brochure a man is “well-educated” about PSA screening.

    I didn’t say that the AUA isn’t attempting to have the balance you suggest. I am saying only that in my opinion (which is just the opinion of one person), I don’t think they have succeeded. I have, this morning, tried to rewrite the section on this site that deals with this issue. I sure as heck know it isn’t easy. I don’t think that my first attempt is even close to sufficient. And I am sure that I shall try to improve on this in coming months.

  6. Mike,

    I am confused. The brochure says: “Early detection and risk assessment of prostate cancer should be offered to men 40 years of age or older who wish to be screened.”

    I did not see “all men need to be tested” mentioned anywhere.

    I think you are making some assumptions that have not been discussed here nor in any of the documents that I have read. Am I missing something? Are you assuming this is what I believe?

  7. No Kathy. That is NOT what I think at all. It has nothing to do with you personally.

    But I DO think that many people are going to interpret the guidance documents as implying that every man should start getting tested at 40 because the wording does not very clearly deny that interpretation.

    My concern is about perceptions and behaviors on the part of those who will try to position the guidance based on their personal beliefs. This is about the politics of prostate cancer testing and diagnosis.

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