Objective: To summarize the experience of the Spanish participation in the European Randomized Study of Screening for Prostate Cancer (ERSPC).
Methods: In this study men aged 45-70 years were randomized (1:1) and allocated to one of two arms: screening, with an indication for transrectal ultrasonography (TRUS) and sextant prostate biopsy when the serum prostate-specific antigen (PSA) level was >4 ng/mL (until May 1998) and from then when the PSA was >2.9 ng/mL; and a control group (no diagnostic tests). The findings from a digital rectal examination were not considered as a criterion for biopsy. When the serum PSA was above the threshold levels, biopsy-negative men were invited again after a year ('early recall'). The next (second) screening round was programmed for the rest of participants after a 4-year interval. Cancer-specific mortality was recorded and compared in both groups.
Results: In all, 4278 men were recruited (2416 in the screening group and 1862 in the control group). The recruitment phase was closed in June 1999. During the first screening round 40 cancers were detected; the detection rate was then 1.7% and 4.15 biopsies were needed to detect each cancer. The clinical stage was localized in 88.6% and regional or metastatic in 11.4%. Within the first round, 17 more cancers were detected at early recall attendance. During the second screening round 14 cancers were found, giving a detection rate of 1.9%; 17 more cancers were also diagnosed outside the screening programme (contamination), seven in the screening group and 10 in the control group. Until February 2003, 85 participants had died (53 screened and 32 control) but none from prostate cancer.
Conclusions: Cancer detection rates can be increased with further early recalls; the clinical stage was localized in an important proportion of cancers detected.