At the Rotterdam site of the ERSPC approximately 9600 men between 54 and 76 years old have been randomized at the time of writing, of which 50% for screening by PSA (Hybritech Tandem E), DRE, and TRUS until March 1996. The cancer detection rate is 4.3%, and the overall biopsy-to-carcinoma rate is 5.1. By clinical staging 91% of cancers are organ-confined (T2c or less), by pathologic staging after radical prostatectomy 64% of tumors are specimen-confined. The best sole predictor of a positive biopsy is total serum PSA, followed by DRE. The specificity of PSA in the intermediate PSA range between 4 and 10 ng/mL can be improved significantly by application of the f-PSA/t-PSA ratio, PSA density and age-specific reference ranges. The f-PSA/t-PSA ratio with a cut-off value of 0.20 appears to be the most effective parameter and reduces in combination with DRE the number of biopsies in the intermediate PSA range by 38% with 12% of carcinomas undetected. This leads to an overall biopsy-to-carcinoma ratio of 4.6. The evaluation of TRUS-, DRE-, and PSA-driven biopsies will lead to a change of the screening procedure within the study.