Prostate-specific antigen as a screening test. The Netherlands experience.

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.