Clinical consequences of screening for prostate cancer:: 15 years follow-up of a randomised controlled trial in Sweden

Objective: To test the feasibility of a population-based prostate cancer screening programme in general practice and explore the outcome after a 15-year follow-up period. Methods: From the total population of men aged 50-69 years in Norrkoping (n = 9026) every sixth man (n = 1494) was randomly selected to be screened for prostate cancer every third year over a 12-year period. The remaining 7532 men were treated as controls. In 1987 and 1990 only digital rectal examination (DRE) was performed, in 1993 and 1996 DRE was combined with a test for Prostate-Specific Antigen (PSA). TNM categories, grade of malignancy, management and cause of death were recorded in the South-East Region Prostate Cancer Register. Results: There were 85 (5.7%) cancers detected in the screened group (SG), 42 of these in the interval between screenings, and 292 (3.8%) in the unscreened group (UG). In the SG 48 (56.5%) of the turnours and in the UG 78 (26.7%) were locallsed at diagnosis (p < 0.001). In the SG 21 (25%) and in the UG 41 (14%) received curative treatment. There was no significant difference in total or prostate cancer-specific survival between the groups. Conclusions: Although PSA had not been introduced in the clinical practice at the start of the study, we were still able to show that it is possible to perform a long-term population-based randormsed controlled study with standardised management and that screening in general practice is an efficient way of detecting prostate cancer whilst it is localised. Complete data on stage, treatment and mortality for both groups was obtained from a validated cancer re gister, which is a fundamental prerequisite when assessing screening programmes. (C) 2004 Elsevier B.V. All rights reserved.