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. 2023 Dec;6(6):566-573.
doi: 10.1016/j.euo.2023.09.008. Epub 2023 Oct 6.

Digital Rectal Examination Is Not a Useful Screening Test for Prostate Cancer

Agne Krilaviciute  1 , Nikolaus Becker  1 , Jale Lakes  2 , Jan Philipp Radtke  2 , Markus Kuczyk  3 , Inga Peters  3 , Nina N Harke  3 , Jürgen Debus  4 , Stefan A Koerber  5 , Kathleen Herkommer  6 , Jürgen E Gschwend  6 , Valentin H Meissner  6 , Axel Benner  7 , Petra Seibold  1 , Glen Kristiansen  8 , Boris Hadaschik  9 , Christian Arsov  2 , Lars Schimmöller  10 , Frederik Lars Giesel  11 , Gerald Antoch  10 , Marcus Makowski  12 , Frank Wacker  13 , Heinz-Peter Schlemmer  14 , Rudolf Kaaks  15 , Peter Albers  16
Affiliations

Digital Rectal Examination Is Not a Useful Screening Test for Prostate Cancer

Agne Krilaviciute et al. Eur Urol Oncol. 2023 Dec.

Abstract

Background: Annual digital rectal examination (DRE) is recommended as a stand-alone screening test for prostate cancer (PCa) in Germany for 45+ yr olds. DRE diagnostic performance in men as young as 45 yr old has not been proved by a screening trial.

Objective: To determine DRE diagnostic performance in a screening trial.

Design, setting, and participants: This analysis was conducted within the multicentric, randomized PROBASE trial, which enrolled >46 000 men at age 45 to test risk-adapted prostate-specific antigen (PSA) screening for PCa.

Intervention: (1) DRE was analyzed as a one-time, stand-alone screening offer at age 45 in 6537 men in one arm of the trial and (2) PCa detection by DRE was evaluated at the time of PSA-screen-driven biopsies (N = 578).

Outcome measurements and statistical analysis: (1) True-/false-positive detection rates of DRE as compared with PSA screening and (2) DRE outcome at the time of a prostate biopsy were evaluated.

Results and limitations: (1) A prospective analysis of 57 men with suspicious DRE at age 45 revealed three PCa. Detection rate by DRE was 0.05% (three of 6537) as compared with a four-fold higher rate by PSA screening (48 of 23 301, 0.21%). The true-positive detection rate by DRE relative to screening by PSA was 0.22 (95% confidence interval [CI] = [0.07-0.72]) and the false-positive detection rate by DRE was 2.2 (95% CI = [1.50-3.17]). (2) Among PSA-screen-detected PCa cases, 86% had unsuspicious DRE (sensitivity relative to PSA was 14%), with the majority of these tumors (86%) located in the potentially accessible zones of the prostate as seen by magnetic resonance imaging.

Conclusions: The performance of stand-alone DRE to screen for PCa is poor. DRE should not be recommended as a PCa screening test in young men. Furthermore, DRE does not improve the detection of PSA-screen-detected PCa.

Patient summary: Our report demonstrated the poor diagnostic performance of digital rectal examination in the screening for prostate cancer in young men.

Keywords: Digital rectal examination; Prostate cancer; Screening.

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