OBJECTIVE: This systematic review examines the diagnostic value of the digital rectal examination (DRE) for the diagnosis of prostate cancer. METHOD: Only studies relating to unselected populations and using either biopsy or surgery as the reference standard were included. The methodological quality of the studies was used in an attempt to explain differences between studies. RESULTS: Fourteen studies were eligible for selection, of which five complied with the predetermined list of 'good-quality' requirements. Between study heterogeneity was high, even within the group of high-quality studies, and could not be explained by the registered indicators of methodological quality. CONCLUSIONS: In this setting, the DRE appears to be a test with a high specificity and negative predictive value, but a low sensitivity and positive predictive value. Neither a positive nor a negative test result is sufficient to enable conclusions without further confirmation.