By Dr. Brian Stone, MD, CEO, Clinical Diversity Solutions
Prostate cancer will be diagnosed in 180,890 men in 2016 and will likely cause the deaths of another 26,120 men in the United States. It is estimated that over 2.8 million men are living with prostate cancer in the US (2013 data). The likely unintended consequence of the United States Preventative Services Task Force (USPSTF) has been the presentation of men in our office with higher PSA levels and more advanced prostate cancer when it is found.
More alarming was the fact that this recommendation included high-risk men who have a strong family history of prostate cancer and African American men. This negative recommendation has created a dilemma for the urologist who must manage reluctant patients and prostate cancer. Even more concerning is the potential reluctance of the “gatekeeper” physician to perform the PSA test in the appropriate age group or to not respect a rising PSA.
Fact: The leading cause of malpractice claims against urologists is the failure to diagnose and treat prostate cancer in a timely manner. Primary care physicians are increasingly liable for failing to obtain PSA testing and failing to refer patients to a urologist.
However, PSA levels can also rise from inflammatory processes (prostatitis, instrumentation, and trauma) and benign prostatic hyperplasia (BPH). PSA is also a good marker for prostatic volume. The PSA blood test is not the perfect screening tool for prostate cancer, but it is the only marker we have for this disease.
Fact: PSA is found primarily in the epithelial cells of the prostate and semen. Low concentrations of PSA have been found in urethral glands, endometrium, normal breast tissue, breast milk, salivary glands, and urine (males & females).
The goal of prostate cancer early detection has always been to detect potentially aggressive and lethal forms of prostate cancer at its earliest stages when treatment can mitigate the morbidity and mortality from the disease. However, it has become evident that “blanket” screening does not detect non-lethal cancers and the treatments are not without potential side effects. A prostate biopsy also carries a very low but real risk of sepsis requiring in-patient treatment. It is clear that the common sense use of PSA and shared decision-making with the patient can help protect patients who are at high risk of being diagnosed with prostate cancer.
Fact: Since PSA was introduced, 75% of men diagnosed with prostate cancer have a non-palpable disease.
The USPSTF's initial negative recommendation was based on one study, the PLCO trial (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial), whose methodology was severely flawed. Over 90% of the men in the control group (allegedly not screened) had indeed been screened, contaminating the data. Additionally, African American men only represented 4% of the cohort in this pivotal study. This was a critical flaw in a study that has been used to make a negative determination about a test that has saved so many lives. Based on SEER mortality statistics, I found this statement on the fact that mortality has steadily declined since the introduction of PSA testing in 1992.
Fact: Prior to the introduction of PSA, 70% of men with prostate cancer presented with extraprostatic or metastatic disease. Since the introduction of PSA, fewer than 3% of men have metastasis at diagnosis.
The Centers for Medicare and Medicaid Services had temporarily suspended the development of a proposed “non-recommended PSA-based screening” measure that would have discouraged PSA screening in all men. After significant protest from the urological community and prostate cancer groups, the USPSTF updated its recommendations for prostate cancer screening in favor of supporting the responsible use of the PSA blood test. The decision-makers (both in policy and the insurance side) must make very well-educated and thoughtful considerations about the fate of the PSA blood test, particularly with the available data that was highly supportive of periodic PSA testing. This reduces the costs and harms of screening while preserving the benefits of yearly testing (based on the AUA guideline for early detection of prostate cancer).
Physicians have sworn the Hippocratic oath, which states that, above all things, “do no harm.” It is evident to me that the blanket denial of educated, patient-involved prostate cancer screening in high-risk populations would be a violation of our oath. While more accurate prostate cancer blood tests continue to be studied, the current PSA assay remains a vital tool in our ability to identify those men at risk of developing the disease.
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