Subset Analysis of Black Men Screened on the PLCO Prostate Cancer Screening Trial
Principal Investigator
Name
Curtiland Deville
Degrees
M.D.
Institution
Johns Hopkins University
Position Title
Assistant Professor of Radiation Oncology and Molecular Radiation Sciences
Email
About this CDAS Project
Study
PLCO
(Learn more about this study)
Project ID
PLCO-172
Initial CDAS Request Approval
Nov 2, 2015
Title
Subset Analysis of Black Men Screened on the PLCO Prostate Cancer Screening Trial
Summary
In May 2012, the United States Preventive Services Task Force (USPSTF) published updated recommendations for prostate cancer screening which recommended against PSA-based screening for prostate cancer. The PLCO PSA prostate cancer screening trial was negative for the primary end point cause-specific mortality, and the USPSTF cited this as one of the major reasons for recommending against PSA screening. Published data from 2015 demonstrated that PSA screening decreased in men over 50 since the 2012 USPSTF recommendations were published.
Although the primary endpoint of the PLCO study was negative, questions remain about whether the data can be applied to men with a higher than average risk of prostate cancer mortality. The recommendation acknowledged the data showing higher prostate cancer incidence and mortality in black men, but given that this population was underrepresented on the trial, the task force concluded that no firm conclusions could be made about the risk and benefits of screening in this population. However, the prostate PLCO publications did not directly examine the effects of screening on black men. The current body of evidence therefore does not exclude a benefit to screening in black men, and it is possible that the reduction in screening will have greater adverse effects of black men given the increased prostate cancer incidence and mortality that they experience.
We therefore propose a race-based subset analysis of men who underwent PSA screening on the PLCO study. We will calculate differences in overall and cause-specific mortality for black men in the screening and usual care groups. Given that the incidence of prostate cancer mortality was low in both arms, we will also calculate differences in diagnosis of Gleason 7 or higher and T3 or higher prostate cancers across arms.
Although the primary endpoint of the PLCO study was negative, questions remain about whether the data can be applied to men with a higher than average risk of prostate cancer mortality. The recommendation acknowledged the data showing higher prostate cancer incidence and mortality in black men, but given that this population was underrepresented on the trial, the task force concluded that no firm conclusions could be made about the risk and benefits of screening in this population. However, the prostate PLCO publications did not directly examine the effects of screening on black men. The current body of evidence therefore does not exclude a benefit to screening in black men, and it is possible that the reduction in screening will have greater adverse effects of black men given the increased prostate cancer incidence and mortality that they experience.
We therefore propose a race-based subset analysis of men who underwent PSA screening on the PLCO study. We will calculate differences in overall and cause-specific mortality for black men in the screening and usual care groups. Given that the incidence of prostate cancer mortality was low in both arms, we will also calculate differences in diagnosis of Gleason 7 or higher and T3 or higher prostate cancers across arms.
Aims
1) Determine whether there was a significant difference in prostate cancer specific mortality among black men in the PSA screening and usual care groups of the PLCO study.
2) Quantify the difference in identification of Gleason 7 or higher and T3 or higher prostate cancer during the active screening period between black men in the screening and usual care group.
3) Determine whether PSA screening is associated with a larger difference in detection of Gleason 7 or higher or T3 or higher prostate cancers in black versus white men.
Collaborators
Christina Chapman, Resident Physician in Radiation Oncology, University of Michigan
Reshma Jagsi, Associated Professor of Radiation Oncology, University of Michigan
Dr. Tsodikov, University of Michigan