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.
To determine DRE diagnostic performance in a screening trial.
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.
(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).
(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.
(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.
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.
Our report demonstrated the poor diagnostic performance of digital rectal examination in the screening for prostate cancer in young men.
European urology oncology. 2023 Oct 06 [Epub ahead of print]
Agne Krilaviciute, Nikolaus Becker, Jale Lakes, Jan Philipp Radtke, Markus Kuczyk, Inga Peters, Nina N Harke, Jürgen Debus, Stefan A Koerber, Kathleen Herkommer, Jürgen E Gschwend, Valentin H Meissner, Axel Benner, Petra Seibold, Glen Kristiansen, Boris Hadaschik, Christian Arsov, Lars Schimmöller, Frederik Lars Giesel, Gerald Antoch, Marcus Makowski, Frank Wacker, Heinz-Peter Schlemmer, Rudolf Kaaks, Peter Albers
Division of Personalized Early Detection of Prostate Cancer, German Cancer Research Center (DKFZ), Heidelberg, Germany., Department of Urology, University Hospital, Medical Faculty, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany., Department of Urology, Medical University Hannover, Hannover, Germany., Department of Radiation Oncology, Heidelberg University Hospital, Ruprecht Karls University Heidelberg, Heidelberg, Germany; Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany., Department of Radiation Oncology, Heidelberg University Hospital, Ruprecht Karls University Heidelberg, Heidelberg, Germany., Department of Urology, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Munich, Germany., Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany., Institute of Pathology, University Hospital Bonn, Bonn, Germany., Department of Urology, University of Duisburg-Essen, Essen, Germany; German Cancer Consortium (dktk), University Hospital Essen, Essen, Germany., Department of Diagnostic and Interventional Radiology, Medical Faculty, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany., Department of Nuclear Medicine, Medical Faculty, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany., Institute of Diagnostic and Interventional Radiology, Technical University Munich, Munich, Germany., Institute of Diagnostic and Interventional Radiology, Medical University Hannover, Hannover, Germany., Department of Radiology, German Cancer Research Center (DKFZ), Heidelberg, Germany., Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany., Division of Personalized Early Detection of Prostate Cancer, German Cancer Research Center (DKFZ), Heidelberg, Germany; Department of Urology, University Hospital, Medical Faculty, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany. Electronic address: .