Adherence to a risk-adapted screening strategy for prostate cancer - first results of the PROBASE trial.

PROBASE is a population-based, randomized trial of 46,495 German men recruited at age 45 to compare effects of risk-adapted prostate cancer (PCa) screening starting either immediately at age 45, or at a deferred age of 50 years. Based on prostate-specific antigen (PSA) levels, men are classified into risk groups with different screening intervals: low-risk (<1.5 ng/ml, 5-yearly screening), intermediate-risk (1.5-2.99 ng/ml, 2 yearly), and high risk (>3 ng/ml, recommendation for immediate biopsy). Over the first 6 years of study participation, attendance rates to scheduled screening visits varied from 70.5 to 79.4%, depending on the study arm and risk group allocation, in addition 11.2-25.4% of men reported self-initiated PSA tests outside the PROBASE protocol. 38.5% of participants had a history of digital rectal examination or PSA testing prior to recruitment to PROBASE, frequently associated with family history of PCa. These men showed higher rates (33%-57%, depending on subgroups) of self-initiated PSA testing in-between PROBASE screening rounds. In the high-risk groups (both arms), the biopsy acceptance rate was 64% overall, but was higher among men with screening PSA ≥4 ng/mL (>71%) and with PIRADS ≥3 findings upon multiparameter magnetic resonance imaging (mpMRI) (>72%), compared to men with PSA ≥3-4 ng/mL (57%) or PIRADS score ≤2 (59%). Overall, PROBASE shows good acceptance of a risk-adapted PCa screening strategy in Germany. Implementation of such a strategy should be accompanied by a well-structured communication, to explain not only the benefits but also the harms of PSA screening.

International journal of cancer. 2022 Sep 19 [Epub ahead of print]

Agne Krilaviciute, Peter Albers, Jale Lakes, Jan Philipp Radtke, Kathleen Herkommer, Jürgen Gschwend, Inga Peters, Markus Kuczyk, Stefan A Koerber, Jürgen Debus, Glen Kristiansen, Lars Schimmöller, Gerald Antoch, Marcus Makowski, Frank Wacker, Heinz Schlemmer, Axel Benner, Frederik Giesel, Roswitha Siener, Christian Arsov, Boris Hadaschik, Nikolaus Becker, Rudolf Kaaks

Division of Personalized Early Detection of Prostate Cancer, German Cancer Research Center (DKFZ), Heidelberg., Department of Urology, University Hospital, Medical Faculty, Heinrich-Heine University Düsseldorf., Department of Urology, Technical University of Munich, School of Medicine, Klinikum rechts der Isar., Department of Urology, Medical University Hannover., Department of Radiation Oncology, Heidelberg University Hospital, Ruprecht Karls University Heidelberg., Institute of Pathology, University Hospital Bonn., Department of Diagnostic and Interventional Radiology, Medical Faculty, Duesseldorf, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany., Institute of Diagnostic and Interventional Radiology, Technical University Munich., Institute of Diagnostic and Interventional Radiology, Medical University Hannover., Department of Radiology, German Cancer Research Center (DKFZ), Heidelberg., Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg., Department of Nuclear Medicine, Medical Faculty, Duesseldorf, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany., Department of Urology, Heidelberg University Hospital, Ruprecht Karls University Heidelberg., Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg.

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