… and during Prostate Cancer Awareness Month men and their families are regularly subjected to messaging about the importance of getting “screened” for risk of prostate cancer.
NO ONE disputes the fact that early detection of clinically significant prostate cancer is an important element in avoiding prostate cancer metastasis and how to manage prostate cancer in an individual patient, if one is unlucky enough to be diagnosed. … NO ONE!
However, …
Many physicians and at least some patient advocates (of whom your sitemaster is very definitely one) have long pointed out that widespread, mass, population-based “screening” of men for their risk of prostate cancer is associated with at least as much potential risk as potential benefit, and is an overly simplistic solution to a very complex problem.
In an ideal world, every man over about 30 years of age should have a clear appreciation of his potential, long-term risk for prostate cancer and how to manage this over the next 40 or so years. But we don’t live in an ideal world, and the majority of men remain sadly under-informed about their individual, personal risks for a whole spectrum of common disorders — prostate cancer included. For example:
- Being diagnosed with prostate cancer does not mean that it is clinically significant; nor does it mean that you will die from it if you don’t get immediate treatment.
- If you are African-American or of other historically “black” sub-Sararahan ethnicity, your risk for prostate cancer is well above average, as is your risk for prostate cancer-specific mortality.
- If you come from a family in which there is a history of prostate cancer, your risk for prostate cancer is also above average (but how much above average depends on the specific prostate cancer history in your family).
- If you come from a family in which there is a history of cancer associated with carriage of the BRCA1 and/or BRCA2 genes, your risk for prostate cancer is higher than average.
- If you were significantly exposed to Agent Orange (before, during, or after the Vietnam War) — and some other environmental hazards — you are at increased risk for diagnosis with prostate cancer (but it remains unclear what level and type of exposure is associated with what level of risk).
- As you get older, your risk for being diagnosed with prostate cancer starts to rise (especially between the ages of about 50 and 70 years), but your risk for dying of prostate may not, because some common forms of prostate cancer do not metastasize.
The critical questions for every single male over about 30 years of age, based on this knowledge, are these ones:
- When do I need to start to take actions to monitor my individual risk for prostate cancer?
- How often do I need to take appropriate steps to monitor any initial signs of my individual risk?
- Is there anything that I should be doing that can lower my risk for prostate cancer?
The answers to all of these three questions have layers of complexity, but there are some that are pretty clear cut:
- If you are an African-American male with a family history of prostate cancer that includes the prostate cancer-specific death of two relatively close male relatives (grandfather, father, uncles, brothers) then you probably want to start talking to a good urologic oncologist about monitoring your risk by the time you are in your late 30s — even though there may be no signs or symptoms of prostate cancer.
- Any individual man’s need for tests for risk of prostate cancer over time is something he needs to come to a mutually agreed decision about with his own doctor or doctors. These decisions are highly individualized and individualizable and depend to a significant extent on the needs and opinions of each specific man.
- Men who are overweight, who smoke, who have high levels of alcohol consumption, and who have very high levels of red meat in their diet appear, generally, to have greater risk for prostate cancer than average. There are many reasons why it would be good to try to manage all of these issues better — if one can.
So having said all of that, we also would bring to readers’ attention that a large, new meta-analysis on data on the value of screening in the management of prostate cancer risk has just been published in the British Medical Journal (the BMJ). In their report, the international group of authors (Ilic et al.) offer the following data
- “Based on four randomized controlled trials reporting this outcome, screening probably has no effect on all-cause mortality …. This corresponds to one less death from any cause per 1,000 participants screened.”
- “PSA screening may have little or no effect on prostate cancer-specific mortality based on five trials reporting this outcome. … This corresponds to zero fewer deaths from prostate cancer … per 1,000 participants screened.”
- “Based on data from four trials, screening may increase the detection of prostate cancer of any stage …. This corresponds to seven more diagnoses of prostate cancer per 1,000 men screened.”
- “Approximately two thirds of men with an elevated PSA level can expect a false positive test result, meaning they will not be diagnosed with prostate cancer.”
- “Approximately 15 percent of men with a PSA level < 4 ng/ml will harbor prostate cancer of any grade consistent with a false negative result."
- “Clinically meaningful disease with a Gleason score ≥ 7 can be expected in 2.3 percent of men with a PSA level < 4 ng/ml."
The important thing for each man over 30 is how to interpret such data in the context of his other known risk factors for prostate cancer as outlined above. Only then can he start to make reasonable decisions about when and how frequently he, as an individual, might need to get tested for his personal risk of prostate cancer and how to best manage that risk.
Filed under: Diagnosis, Management, Risk | Tagged: risk, screening, testing |
The Devil (Or Angel) is in the Details
I hope to read that BMJ study published this week via the link provided to the complete paper. My hunch is that some of their summary conclusions need a huge mount of salt for proper digestion, such as the comment in the second bullet above that “PSA screening may have little or no effect on prostate cancer-specific mortality based on five trials reporting this outcome. … This corresponds to zero fewer deaths from prostate cancer … per 1,000 participants screened.” PLCO is one of those trials, and as previously reported and discussed here that trial is useless at providing insight into the benefits of screening, largely because of the very high level of contamination in the study. In other words, a very heavy proportion of patients in the usual care arm (as contrasted to the arm that emphasized screening per protocol) were screened. This BMJ study notes this in a nice graphic, but it still counts the study in it’s “… five trials …” comment. Even worse, their comment suggesting zero benefit from screening 1,000 men is not only bound to motivate men to forego screening but is also contrary to conclusions in the European Randomized Study of Screening for Prostate Cancer (ERSPC).
My concern is that this and perhaps many other major flaws will influence men to forego screening and suffer the consequences.
The message I sent out, if you wish to print it despite its length, was as follows:
September is “Prostate Cancer Awareness Month” and this e-mail is forwarded for information to all friends and family and hopefully be forwarded further to their friends and family who may not recognize the importance of annual testing for prostate cancer for men beginning at age 35 if there is a background of prostate cancer or breast cancer in the family or if African American; others beginning at 45 years of age. The term “an ounce of prevention” is of particular importance with this disease that can become deadly (I am not trying to cause fear, but rather express the seriousness that can come with prostate cancer if not diagnosed early in development). The earlier developing prostate cancer is diagnosed, the less chance that cancer has developed to where treatment cannot eradicate it. When men put off visiting with a Urologist when experiencing ANYTHING unusual in urinating, urinating pain, slow urinating, multiple times getting up at night to urinate, or any urinary discomfort, they are at risk that when these problems get worse requiring they had better see their family doctor or Urologist, too often that cancer has grown to the point it has moved outside the prostate gland (metastasized to other organs) at which time treatment will likely be more difficult requiring multiple therapies to bring under control/management – or worse. It is important that all of you receiving this address this serious problem to your male family members and friends falling with the foregoing age group. The life you save may be that family member or friend.
This message is also being sent to several male friends whom I am well aware have already experienced this disease to encourage you to pass this on to your family members and friends. We can never overstate the importance of early testing with a simple Prostate-Specific Antigen/PSA blood test accompanied by an also simple Digital Rectal Exam/DRE wherein one or the other or both may identify any suspicious activity.
I, also, serve as a mentor to help men, caregivers, or anyone interested understand this disease of men, treatment options available if diagnosed, and treatment of side effects that most often accompany any treatment options. See: http://www.theprostateadvocate.com
Dear Jim:
What you keep forgetting is that just as there are serious problems that bias the data from the PLCO trial, there are also serious problems that bias the data from the ERSPC trial as well. All these trials have been flawed in different ways and one of the flaws of the ERSPC is that the data from Sweden came from a single center (Goteborg) where no one had ever been tested for risk of prostate cancer prior to initiation of the trial. As an almost inevitable consequence, this set of data provided an unusually highly positive outcome compared to all the rest of the ERSPC data.
The value of a meta-analysis is that it “evens out” the flaws in the individual trials.
Please note what I wrote above. “NO ONE disputes the fact that early detection of clinically significant prostate cancer is an important element in avoiding prostate cancer metastasis and how to manage prostate cancer in an individual patient, if one is unlucky enough to be diagnosed. … NO ONE!” However, there is a vast gulf between that fact and the idea that “screening” is a good idea for most of the male population in a specific country — unless it is being done with a significant emphasis on a very clear understanding of individual risk over time and exactly what one is “screening” for. That’s what shared decision making is all about, as compared to the constant, mindless messaging that every man should “get screened” which we see during September each year.
You have made it clear that you are approaching the data in the study above from a biased perspective. This is not a good idea.
Dear Chuck:
I appreciate your passion, however … I would profoundly disagree with your statement about the need for annual PSA tests for the majority of men after any age, although I would concur with you about the need for DREs in addition to PSA tests when a set of tests for risk of prostate cancer is being carried out. Testing, in my humble opinion, is something that needs to be based on the risk profile of the particular individual, and not on some arbitrary idea that every man is at the same level of risk for either being diagnosed with or possibly dying from prostate cancer.