PHEN Comments on Task Force Prostate Cancer Screening Research Plan
The Prostate Health Education Network, Inc. (PHEN) appreciates the opportunity to provide comments on the U. S. Preventive Services Task Force’s (USPSTF) draft research plan for prostate cancer screening. PHEN is the leading prostate health patient education and advocacy organization with a focus on the needs of the African-American population.
PHEN comments are as follows:
1. African-American men (AAM), the population most impacted by prostate cancer (PCa) within the United States, are deemed a “high – risk population” for the disease. According to the National Cancer Institutes’ SEER data, AAM have a PCa incidence rate 1.6 times higher than men of European (EM) descent in the U.S., and a mortality rate that is more than 2.4 times higher than EM. This racial disparity is the largest for any type of major cancer. U. S. Senate Resolution 529, passed in 2012, recognized PCa among AAM as a health crisis of epidemic proportion. In addition, studies show that AAM are diagnosed at an earlier age than other populations with more aggressive disease.
2. The USPSTF research plan should make provisions to thoroughly assess the benefits and harms of PSA early detection screening for high-risk populations, with the AAM population being at the highest risk level. The research plan should reflect a clear categorization between average-risk populations and high-risk populations at every level of design (population, setting, interventions, comparisons, outcomes, durations, study designs, study quality, language and timeframe). Studies without an AAM participation rate of at least 10 percent should not be included as evidence for the high-risk category.
3. The USPSTF recommendation should include separate recommendations for high-risk and average-risk populations based entirely on the evidence for each risk category. There should be no extrapolations or assumptions of evidence across the high-risk and average-risk categories where data may be absent.
The 2013 USPSTF recommendation for lung cancer screening is a precedent for the risk categorized approach that PHEN suggests. The 2004 USPSTF lung cancer screening recommendation was a grade I for the total population. However, the USPSTF 2013 recommendation for the population deemed to be at high-risk for lung cancer was upgraded to a grade level B.
The evidence used to formulate the 2013 lung cancer recommendation included inputs from the Cancer Intervention and Surveillance Modeling Network (CISNET). CISNET models have been used to evaluate benefits and harms of PSA screening and suggest that 45% to 70% of the prostate cancer mortality decline observed since the widespread use of PSA testing beginning in the 1990’s could be attributed to the stage-shift at diagnosis induced by PSA screening. In addition, a study published in the New England Journal of Medicine (NEJM) on Oct. 28, 2015, attributes this PSA screening stage-shift for cutting the metastatic prostate cancer rate at diagnosis by 50%; a significant benefit in reducing patient morbidity.
Citing the 2013 USPSTF lung cancer screening evidence analysis as a precedent, CISNET modeling data should be included as part of the research plan for the prostate cancer screening evidence base. Also, the research plan’s approach “study design” evidence window should be broadened beyond randomized controlled trials to incorporate the NEJM and similar studies.
These comments are intended to support the USPSTF efforts to develop a fair and effective PSA test screening recommendation for all men, and to insure that the assessment of benefits and harms of prostate cancer screening for the populations at high-risk for prostate cancer are not minimized, or subjugated, as they were with USPSTF’s 2012 prostate cancer screening recommendation.