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No AccessJournal of UrologyAdult Urology1 Apr 2018Use of Digital Rectal Examination as an Adjunct to Prostate Specific Antigen in the Detection of Clinically Significant Prostate Cancer Joshua A. Halpern, Clara Oromendia, Jonathan E. Shoag, Sameer Mittal, Michael F. Cosiano, Karla V. Ballman, Andrew J. Vickers, and Jim C. Hu Joshua A. HalpernJoshua A. Halpern Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York More articles by this author , Clara OromendiaClara Oromendia Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, New York More articles by this author , Jonathan E. ShoagJonathan E. Shoag Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York More articles by this author , Sameer MittalSameer Mittal Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York More articles by this author , Michael F. CosianoMichael F. Cosiano Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York More articles by this author , Karla V. BallmanKarla V. Ballman Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, New York More articles by this author , Andrew J. VickersAndrew J. Vickers Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York More articles by this author , and Jim C. HuJim C. Hu Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York Financial interest and/or other relationship with Intuitive Surgical and Genomic Health. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.10.021AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Guidelines from the NCCN® (National Comprehensive Cancer Network®) advocate digital rectal examination screening only in men with elevated prostate specific antigen. We investigated the effect of prostate specific antigen on the association of digital rectal examination and clinically significant prostate cancer in a large American cohort. Materials and Methods: We evaluated the records of the 35,350 men who underwent digital rectal examination in the screening arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening trial for the development of clinically significant prostate cancer (Gleason 7 or greater). Followup was 343,273 person-years. The primary outcome was the rate of clinically significant prostate cancer among men with vs without suspicious digital rectal examination. We performed competing risks regression to evaluate the interaction between time varying suspicious digital rectal examination and prostate specific antigen. Results: A total of 1,713 clinically significant prostate cancers were detected with a 10-year cumulative incidence of 5.9% (95% CI 5.6–6.2). Higher risk was seen for suspicious vs nonsuspicious digital rectal examination. Increases in absolute risk were small and clinically irrelevant for normal (less than 2 ng/ml) prostate specific antigen (1.5% vs 0.7% risk of clinically significant prostate cancer at 10 years), clinically relevant for elevated (3 ng/ml or greater) prostate specific antigen (23.0% vs 13.7%) and modestly clinically relevant for equivocal (2 to 3 ng/ml) prostate specific antigen (6.5% vs 3.5%). Conclusions: Digital rectal examination demonstrated prognostic usefulness when prostate specific antigen was greater than 3 ng/ml, limited usefulness for less than 2 ng/ml and marginal usefulness for 2 to 3 ng/ml. These findings support the restriction of digital rectal examination to men with higher prostate specific antigen as a reflex test to improve specificity. It should not be used as a primary screening modality to improve sensitivity. References 1 : Evidence of prostate cancer “reverse stage migration” toward more advanced disease at diagnosis: data from the Pennsylvania Cancer Registry. Urol Oncol2016; 34: 335.e21. Google Scholar 2 : Increasing incidence of metastatic prostate cancer in the United States (2004-2013). Prostate Cancer Prostatic Dis2016; 19: 395. Google Scholar 3 : Early detection of prostate cancer by routine screening. JAMA1984; 252: 3261. 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Google Scholar © 2018 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byTosoian J, Trock B, Morgan T, Salami S, Tomlins S, Spratt D, Siddiqui J, Kunju L, Botbyl R, Chopra Z, Pandian B, Eyrich N, Longton G, Zheng Y, Palapattu G, Wei J, Niknafs Y and Chinnaiyan A (2020) Use of the MyProstateScore Test to Rule Out Clinically Significant Cancer: Validation of a Straightforward Clinical Testing ApproachJournal of Urology, VOL. 205, NO. 3, (732-739), Online publication date: 1-Mar-2021.Aminsharifi A, Howard L, Wu Y, De Hoedt A, Bailey C, Freedland S and Polascik T (2018) Prostate Specific Antigen Density as a Predictor of Clinically Significant Prostate Cancer When the Prostate Specific Antigen is in the Diagnostic Gray Zone: Defining the Optimum Cutoff Point Stratified by Race and Body Mass IndexJournal of Urology, VOL. 200, NO. 4, (758-766), Online publication date: 1-Oct-2018.Smith J (2018) This Month in Adult UrologyJournal of Urology, VOL. 199, NO. 4, (863-864), Online publication date: 1-Apr-2018. Volume 199Issue 4April 2018Page: 947-953Supplementary Materials Advertisement Copyright & Permissions© 2018 by American Urological Association Education and Research, Inc.Keywordsearly detection of cancerprostate-specific antigendigital rectal examinationprostatic neoplasmsmass screeningAcknowledgmentsNCI (National Cancer Institute) provided access to NCI data collected in the PLCO Cancer Screening Trial.MetricsAuthor Information Joshua A. Halpern Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York More articles by this author Clara Oromendia Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, New York More articles by this author Jonathan E. Shoag Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York More articles by this author Sameer Mittal Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York More articles by this author Michael F. Cosiano Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York More articles by this author Karla V. Ballman Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, New York More articles by this author Andrew J. Vickers Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York More articles by this author Jim C. Hu Department of Urology, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York Financial interest and/or other relationship with Intuitive Surgical and Genomic Health. More articles by this author Expand All Advertisement PDF downloadLoading ...