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Randomized Controlled Trial
. 2018 Apr;199(4):947-953.
doi: 10.1016/j.juro.2017.10.021. Epub 2017 Oct 20.

Use of Digital Rectal Examination as an Adjunct to Prostate Specific Antigen in the Detection of Clinically Significant Prostate Cancer

Joshua A Halpern  1 , Clara Oromendia  2 , Jonathan E Shoag  1 , Sameer Mittal  1 , Michael F Cosiano  1 , Karla V Ballman  2 , Andrew J Vickers  3 , Jim C Hu  4
Affiliations
Randomized Controlled Trial

Use of Digital Rectal Examination as an Adjunct to Prostate Specific Antigen in the Detection of Clinically Significant Prostate Cancer

Joshua A Halpern et al. J Urol. 2018 Apr.

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.

Keywords: digital rectal examination; early detection of cancer; mass screening; prostate-specific antigen; prostatic neoplasms.

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Figures

Figure 1 –
Figure 1 –
Cumulative incidence of clinically significant prostate cancer (CSPC) by prostate-specific antigen (PSA) level at most recent screen
Figure 2 –
Figure 2 –
Cumulative incidence of clinically significant prostate cancer (CSPC) according to clinical prostate-specific antigen (PSA) level grouping at most recent screen
See this image and copyright information in PMC

References

    1. Reese AC, Wessel SR, Fisher SG, Mydlo JH. Evidence of prostate cancer “reverse stage migration” toward more advanced disease at diagnosis: Data from the Pennsylvania Cancer Registry. Urol Oncol. 2016;34(8):335 e21–8. doi: 10.1016/j.urolonc.2016.03.014. - DOI - PubMed
    1. Weiner AB, Matulewicz RS, Eggener SE, Schaeffer EM. Increasing incidence of metastatic prostate cancer in the United States (2004–2013). Prostate cancer and prostatic diseases. 2016;19(4):395–7. doi: 10.1038/pcan.2016.30. - DOI - PubMed
    1. Chodak GW, Schoenberg HW. Early detection of prostate cancer by routine screening. JAMA. 1984;252(23):3261–4. - PubMed
    1. Catalona WJ, Richie JP, Ahmann FR, Hudson MA, Scardino PT, Flanigan RC, et al. Comparison of digital rectal examination and serum prostate specific antigen in the early detection of prostate cancer: results of a multicenter clinical trial of 6,630 men. J Urol. 1994;151(5):1283–90. - PubMed
    1. Beemsterboer PM, Kranse R, de Koning HJ, Habbema JD, Schroder FH. Changing role of 3 screening modalities in the European randomized study of screening for prostate cancer (Rotterdam). Int J Cancer. 1999;84(4):437–41. - PubMed

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