In 2011, the U.S. Preventative Services Task Force (USPSTF) -- an independent panel that systematically reviews scientific evidence - issued a controversial recommendation against prostate screening for all men. This action was taken following the results of the nationwide Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) Screening Trial, designed and sponsored by the National Cancer Institute, which showed no significant survival advantage for men undergoing PSA screening for prostate cancer.
Thankfully, the USPSTF's recommendation does not preclude health care providers from exercising their own clinical judgment. However, because of this recommendation, the federal government, specifically the Centers for Medicaid & Medicare Services, in a rather clandestine move, is now considering economically penalizing health care providers who order PSA screening for Medicare patients. I find this incomprehensible!
The fact remains there are two glaring deficiencies in the PLCO study as it pertains to prostate cancer. First, over 70% of men in the control -- or unscreened -- arm of the study actually underwent PSA screening. Secondly, the duration of follow-up with these individuals was inadequate to appropriately elucidate the benefits of PSA screening on mortality.
It also is important to note that not a single health care professional who manages prostate cancer has been appointed to the USPSTF to provide hands-on, clinical perspective to its recommendations.
The most compelling statistic which is not subject to vagaries of study or research design is mortality rates. And on this score, the facts are indisputable: Over the past decade in the US, we have seen a 40% decline in the death rate from prostate cancer - the cancer that is second only to lung cancer as a killer of American males.
Given their 2011 recommendation, how does the USPSTF reconcile this impressive and indisputable decline in mortality? Is it the injudicious and early use of androgen deprivation therapy (ADT) which has never been shown to increase survival in a controlled trial? Is it the most recent advances in chemotherapy, immunotherapy or secondary ADT which, most experts will not dispute increases survival by, at best, about three months?
It is clear that the most compelling explanation is early detection - specifically through PSA screening.
Owing to the prolonged natural history of prostate cancer, one would predict that declining mortality rates would be observed approximately 10 years following widespread adoption of PSA screening, which would be consistent with the mortality statistics. The USPSTF seems blind to this reality.
The many healthy men who harbor intermediate or high risk disease - and who most experts deem are appropriate candidates for aggressive local therapy -- will likely suffer under this policy. Quite simply, it will lead to delayed diagnosis and potentially an increase in mortality rates. Certainly not the direction we want to go.
So, what's the sensible solution? I am a strong believer that PSA screening saves lives. However, those of us who embrace and remain advocates of such testing must reconcile and find solutions for the major limitations of the accepted paradigm for PSA screening, random prostate biopsy and indiscriminate treatment of detected prostate cancer.
We all recognize that PSA lacks specificity for detecting aggressive prostate cancer, which, in turn, leads to many unnecessary biopsies. And while a random, systematic 12-core biopsy detects many insignificant cancers, they miss many aggressive cancers. We also recognize that many low risk cancers do not require immediate curative intervention.
However, there are tools to address the limitations of PSA screening and the downstream consequences of unnecessary biopsies and treatment. In my own clinical practice, I have adopted both multi-parametric MRI imaging and the 4KScore Test, a blood test, in order to identify those men with an elevated PSA who are most likely to harbor aggressive prostate cancer. When these tests suggest a low risk of aggressive disease, prostate biopsy is deferred.
And my home institution, NYU Langone Medical Center, has pioneered using complex computer software to target our prostate biopsies into areas of the gland most likely to harbor aggressive disease.
The USPSTF has oversimplified a complex problem. The urology community is, in fact, embracing strategies to preserve, or even further decrease, prostate cancer mortality while minimizing the unnecessary morbidity and costs associated with the prior standard of care.
If the government, indeed, institutes penalties for performing PSA screening, it will exacerbate decreasing trends in PSA screening. And that, in turn, will prove to be a tremendous disservice for many men whose suffering and/or death from prostate cancer would have otherwise been preventable.
Dr. Lepor is the Martin Spatz Professor and Chair of the Department of Urology at NYU Langone Medical Center and co-author of the best-selling consumer guide, "Redefining Prostate Cancer."