The Prostate Conditions Education Council, as a key patient advocacy organization, agree with Dr. Matt Cooperberg’s assessment. Our global experts in Urology believe that the USPSTF reached the wrong conclusion with their "D" recommendation against screening. The panel lacks specialists, rejected many key opinions by both clinical and statistical content experts. As a result, their evidence review was based on a fundamentally flawed interpretation of the existing evidence base. As just a few examples:
• The PLCO trial, by the trial authors' own statement, was not a trial of screening vs. no screening; it was a trial of annual screening vs. opportunistic screening and 50% of the control group received screening. It therefore should not have been included as evidence against screening.
• The USPSTF statement re: absence of benefit at 8-10 years follows indicates a poor understanding of the intent of screening. The benefits only start to accrue at 8 years and take much longer to be fully realized. A man with an 8-10 life expectancy should not be screened, and this is not controversial.
• The USPSTF focused specifically on literature to find worst-case scenarios re: harms of treatment. E.g., they cite a 0.5% perioperative mortality rate for prostatectomy, based on out-dated papers reporting data from low-volume surgeons treating only older men. They ignored, e.g., a JAMA study showing a 10-fold lower rate in contemporary practice (http://dx.doi.org/10.1001/jama.2009.1451).
• The USPSTF completely ignored risk factors like race and family history. African-American men are completely under-represented in all available data sources on screening, and are known to have much higher rates of prostate cancer and lethal prostate cancer.
The USPSTF is the only major guideline recommending against all screening. Most others, including the NCCN, AUA, ACS, and ACP/ASIM, PCEC recommend some variation on shared decision-making recognizing both benefits and harms of screening.
There is no question that PSA screening has not been implemented optimally in the U.S.—we tend to start screening too late, we repeat screening too frequently, we continue too late among men with comorbidity, and we often overtreat low-risk disease and undertreat high-risk disease. The solution, however, is not to abandon screening but rather to screen smarter. Men with good life expectancy should be screened early, and, if the baseline is low, much less frequently. Further, screening should not be discontinued if there is an issue with over treatment, rather the overtreatment should be addressed allowing those men who choose to participate in early detection have the opportunity to find clinically relevant and deadly disease at a time which it can be treated a save lives.
Low-risk disease should rarely be treated, and recent evidence shows that rates of active surveillance are rising very rapidly (http://dx.doi.org/10.1001/jama.2015.6036). But high-risk disease needs to be found early and treated aggressively. Screening and better treatment explain ≥60% of the over 50% drop in prostate cancer mortality rates we have seen since the 1990s (http://dx.doi.org/10.1002/cncr.27594), and it is a mathematical certainty that if we abandon screening wholesale we will be return to the 1980s in terms of metastatic disease levels (http://dx.doi.org10.1002/cncr.28932), and given the aging population and new treatments available, this will equate to an extraordinary burden of entirely avoidable suffering, early mortality, and costs to the healthcare system. Early data following the 2012 "D" recommendation suggest that we have seen a 25% drop in overdiagnosis of low-risk disease—and a 25% drop in diagnosis of high-risk disease as well which implies a comparable increase in underdiagnosis. (http://dx.doi.org/10.1016/j.juro.2015.06.075).
Final specific comments on the proposed CQM: 1) 4.0 is no longer recognized as a uniform threshold. A PSA above 4 for an older man with BPH may be unconcerning, but a PSA even above 1 for a healthy 50 year old would at least justify follow-up repeat retesting. 2) "Dysplasia" of the prostate is a nonspecific term that does not correspond to any current pathological diagnosis. 3) LUTS (voiding symptoms) and BPH are also absolute indications for PSA.
In closing, to establish a CQM on this issue suggests that consensus exists where in fact a raging controversy continues. In fact, even the USPSTF will be re-addressing the question and has just opened public comment on their evidence plan. PSA screening should be improved not abandoned, and this CQM would be a major step in the wrong direction, and exactly the wrong time.
Feel free to contact us at wendy.poage@prostateconditions.org