Screening for prostate cancer without digital rectal examination and transrectal ultrasound: Results after four years in the European Randomized Study of Screening for Prostate Cancer (ERSPC), Rotterdam

BACKGROUND Omission of DRE/TRUS as biopsy indication results in fewer unnecessary biopsies, but may increase the risk of missing potentially aggressive prostate cancers (PCs). In 1997, the biopsy indication within the ERSPC was changed from a PSA cut‐off of 4.0 ng/ml and/or abnormal DRE/TRUS (group‐1) to solely a PSA cut‐off of 3.0 ng/ml (group‐2). We estimated the effect of omitting DRE/TRUS by comparing the results of a re‐screening 4 years after initial screening to the original policy. METHODS We compared rate and characteristics of detected PCs in the second round in men initially screened in group‐1 (N = 5,957) or group‐2 (N = 8,044). Additionally, we compared the rate of interval cancers (ICs) after screening with and without DRE/TRUS. RESULTS There was no significant difference in second round cancer‐detection‐rates (group‐1, 3.0%; group‐2, 2.7%), positive‐predictive‐values (group‐1, 23.9%; group‐2, 26.3%), and number of poorly‐differentiated tumors (group‐1, 2.6%; group‐2, 3.8%). Most PCs were clinically confined to the prostate. Eleven ICs were detected in each group (0.18 and 0.14%). CONCLUSIONS Omitting DRE/TRUS did not result in an increased IC‐ or PC‐detection. However, considering the natural history of PC, the 4‐year follow‐up may be too short to draw a definitive conclusion. Prostate 66:625–631, 2006. © 2005 Wiley‐Liss, Inc.