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To assess the role of a digital rectal examination (DRE) in the clinical diagnosis of prostate cancer and in predicting the pathological stage, as the diagnosis of early prostate cancer usually comprises prostate-specific antigen (PSA) testing, a DRE and transrectal ultrasonography (TRUS)-guided biopsies.Over the 4 years between 2000 and 2004, 408 consecutive patients (mean age 63.8 years) referred with age-specific PSA levels of 2.5–10.0 ng/mL and who had a TRUS-guided 12-core prostate biopsy were included in the study. They had a DRE by either of two experienced consultant urologists. The results of the DRE and core biopsy histology were compared with the histology and the radical prostatectomy specimen in a subset (82 men) of the study population.Cancer was detected on biopsy in 152 patients; of the 196 with an abnormal DRE, 47% had cancer on biopsy. In the patients with a normal DRE, 59 cancers were detected. Men with cancer were older and had a higher median PSA level. There was no correlation between the DRE and biopsy findings, and none between an abnormal DRE and histological diagnosis of cancer. Of the patients who had a radical prostatectomy, 38% had a normal DRE.There was no correlation between the DRE, biopsy findings and pathological staging. The DRE did not contribute to managing patients with prostate cancer, but this does not mean that there is no longer a place for the DRE in assessing the urological patient. If patients are appropriately counselled before PSA testing, a DRE may not be essential for patients with a PSA level of 2.5–10 ng/mL.