Shared and emotion-free decision-making with respect to PSA-based screening

The following is (slightly edited) report by Jeffrey J. Tomaszewski, MD, on behalf of, of a state-of-the-art lecture by David Penson, MD, presented at the annual meeting of the American Urological Association (AUA) in Orlando. We hope that UroToday will forgive us for this direct “theft”, but the topic is one of enormous relevance to the patient community.

Dr. David Penson presented a state-of-the-art lecture on evidence-based versus consensus-based guidelines on PSA testing. Consensus-based guidelines are developed by experts who informally evaluate and establish recommendations. Evidence-based guidelines use an unbiased and transparent process determined a priori. To give a historical context, prior to 2009 there were no high-quality, completed, randomized control trials (RCTs) directly randomizing men to screening vs. non-screening. All guidelines prior to 2009 that made definitive recommendations were based on expert consensus/opinion.

Then, in 2009, results from the ERSPC and PLCO trials were released. The PLCO trial was a negative but flawed study, finding no significant difference in prostate cancer death between screening and usual care. The ERSPC trial was positive, but not positive enough. At 11 years of follow-up, there was a significant difference in the cumulative hazard of death from prostate cancer. There have been five guidelines released on prostate cancer screening. The three consensus-based guidelines are those of the American College of Physicians (ACP), the National Comprehensive Cancer Network (NCCN), and the American Cancer Society (ACS), while the two evidence-based guidelines are those of the AUA and the U.S. Preventive Services Task Force (USPSTF).

Among all five guidelines, there is just one key point of agreement: population-wide routine screening without informed consent (e.g., mass PSA testing at health fairs) is not recommended. Those who feel screening should be considered propose shared decision-making in which the patient is informed. The ACP suggests men aged 50-69 years should be informed about the limited potential benefits and substantial harms of prostate cancer screening. These guidelines, however, are not evidence or consensus based, leading Dr. Penson to “dismiss these guidelines.” The NCCN guidelines represent a statement of the evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. The strength of PSA testing recommendations varies with age 45-49 years (category 2b); 50-70 years (category 2a); age ≥ 70 years (category 2b). The ACS guidelines state that for normal risk men, informed decision making should start at the age of 50, and not be offered for patients with a < 10-year life expectancy.

The problem with consensus-based guidelines is the introduction of bias based on the constitution of the expert panel. Panel experts have preconceived notions, and uniform consensus cannot always be achieved. So what makes a trustworthy evidence-based guideline? They should be based on a systematic review of the evidence, be developed by a multidisciplinary panel, and be based on explicit and transparent processes. So why are the USPSTF prostate cancer screening guidelines so discordant with other guidelines? There were no cancer specialists or survivors on the USPSTF panel, and bias was introduced in the a priori inclusion criteria used for systematic review. USPSTF elected not to use simulation models that show a benefit for prostate cancer screening, but used such models in the breast cancer screening guidelines. Dr. Penson said, “the 2012 USPSTF recommendation was a foregone conclusion.”

So what lessons can be learned? Evidence-based guidelines are preferred but far from perfect. Bias can be introduced into even the most transparent processes. What should urologists do? “No one is suggesting population-wide screening, but rather, shared decision making. Urologists should reconsider the entire discussion with an open mind, and emotional and anecdotal arguments have no role.” We must be honest with our patients and ourselves; if not, there will be widespread ramifications.

The “New” Prostate Cancer InfoLink wishes to clearly concur with and emphasize Dr. Penson’s statement and recommendation reported in the final paragraph above. It bears repeating:

No one is suggesting population wide screening, but rather, shared decision making. Urologists should reconsider the entire discussion with an open mind, and emotional and anecdotal arguments have no role.

Members of the patient advocacy community might also want to take this statement and recommendation to heart.

12 Responses

  1. What I find fascinating in this PSA discussion is that US males of age have to find a way to get vetted for prostate health. In my opinion, the only way to get it is with a PSA test or a DRE — which most men appear to avoid.

    So, either we train our German Shepherd to sniff our urine for prostate cancer or we have our wives trained to do DRE since PSA is just sooo controversial.

  2. Jim:

    Well at least you aren’t suggesting that we train our wives to sniff our urine!

    The baseline problem is that most of us men think we are immortal until it becomes evident that we aren’t. Many of us then expect there to be miracles available to which we are entitled in some way. How many men do you know, under the age of 40, that actually spend any serious time thinking about their long-term health risks and what they really ought to be doing to minimize these risks? This is not a prostate-only problem. It is a fundamental problem in dealing with men and their health.

  3. I agree, Mike. It seems that now we are all living longer, US males of all ages feel immune to rational discussion on health issues.

    On another note, check out the post on my blog. It is from a guy who frequents the prostate cancer blogs where serious comments are posted, who is one year out of surgery, and is about how to announce his cancer at the Thanksgiving day table! I find it hilarious.

  4. It seems that the 4Kscore test would be a vast improvement and provide significant help in this area of decision making. I look forward to reading your reaction to the data presented at the AUA plenary session both technically, as it relates to 4Kscore itself, and the the post regarding the utility of biomarker based testing, and this topic.

  5. Dear OneFreeT:

    We commented on the 4KScore data a while back, when the late-breaking abstract was made available. I don’t get the impression that there were any additional data actually presented at the AUA meeting.

    It would appear to me that, as we said then, the 4KScore test “holds considerable potential”. However, a number of factors are going to affect the real value of this test, starting with how much it costs, and whether the “real world” data match-up to the clinical trials data. A question that may be of importance here, for example, is whether the 4KScore test should be used only in men who appear to have an elevated PSA result that might justify a biopsy (as a way to confirm that a biopsy is really necessary). I would suspect that cost is going to eliminate the value of the 4KScore test as a primary screening tool.

    The other thing I am still trying to understand is why — when the 4KScore test has been available in Europe for an extended period of time now — we have heard almost nothing about its use in Europe. If it really does cut down on the need for biopsies, why would it not be used to do that?

  6. In my opinion, anything that reduces the need for a biopsy is a hammer in the tool box of diagnosis. At what point (percent of biopsy cost) does a test become an acceptable (insurance company cost benefit) alternative?

  7. Chris:

    I can’t answer that question. What I do know is that the costs of these newer tests is actually significantly higher than the cost for a standard, 12-core biopsy and the associated pathology report.

  8. Just found this article today: “4KScore identifies high-grade prostate cancer, prebiopsy” at Medscape. It includes the statement that, “The 4KScore test is $395”. And this as well: ‘However, Dr. Loeb said that another prebiopsy blood test, the Prostate Health Index (PHI), is “similarly effective in detecting high-risk prostate cancer.” PHI is also considerably cheaper — at just $80, said Dr. Loeb, who has been a PHI investigator.’

    Seems to me there are some excellent screening methods within reason. If one’s insurance is unwilling to pay, these costs are certainly low enough for every man to consider “treating” themselves.

  9. What is the average cost of a 12-core biopsy and the associated pathology report that you are refering to for the price comparison?

  10. According to the Healthcare Bluebook, a “fair” price for a prostate biopsy (inclusive of the pathology) is $1,928. However, there is vast variation in what is actually charged for a biopsy. I have seen costs that are significantly lower than this, and I have seen bills that are massively higher.

  11. I think that its incorrect to state then, that generally speaking all the new tests costs are significantly higher, or even higher at all. The 4kscore test is $395.00. It also seems it would be worth classifying these new tests as biomarker-ased indicator, genetic predictor, and then genetic markers of actual extracted prostate tissues, etc., in the context of when these new tests would be used vs. a previous method would be helpful, i.e., genetic predisposition as a substitute for family history; PSA and a 4Kscore vs. having or not having a biopsy; a biopsy vs. some other genetic marker matching test (i.e., the urine test). Clearly there are stages where the new tests are significantly higher. However, the cost of PSA and a subsequent 4Kscore if elevated vs. a biopsy at almost $2,000, assuming no complications, seems to offer a significant savings and patient benefit. A patient could stay on active surveillance for 5 years getting a 4Kscore annually for the cost of a single biopsy with no complications.

  12. Dear OneFreeT:

    I only ever stated that the genomic tests like Prolaris were more expensive than a biopsy. We need a lot more work done with all of these new tests to be able to know how best to actually utilize them. To date there is less than a year’s actual “real life” clinical experience with many of these tests.

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