Approximately half of the tumors missed with PSA 0 to 4 ng./ml. had aggressive characteristics (Gleason score 7 or greater, Gleason 4-5 components) and were organ confined. These tumors should be diagnosed and treated according to the present understanding of their natural history. More sensitive and selective screening strategies are needed. Presently a wrong "window of opportunity" is used for early detection of prostate cancer.

Approximately half of the tumors missed with PSA 0 to 4 ng./ml. had aggressive characteristics (Gleason score 7 or greater, Gleason 4-5 components) and were organ confined. These tumors should be diagnosed and treated according to the present understanding of their natural history. More sensitive and selective screening strategies are needed. Presently a wrong "window of opportunity" is used for early detection of prostate cancer.

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.