Prostate cancer is currently the most common cancer among men after skin cancer in most industrialized countries (Parkin et al, 1997). Because of its poorly understood aetiology, primary prevention is not currently feasible and therefore there is considerable interest in screening as a potential approach to prostate cancer control (Schršder and Boyle, 1993). The only means to establish the effect of screening is to conduct large randomized controlled trials with both mortality and quality of life as end points (Denis et al, 1995). Such studies are ongoing both in Europe and North America (Auvinen et al, 1996). In the absence of empirical results, a debate of the issue continues, which is demonstrated by the fact that so far the number of published reviews on the subject exceeds the number of original reports of randomized trials (as identified from Medline).We report here the first-year results of the Finnish trial, which is part of the European Randomized Study of Screening for Prostate Cancer (ERSPC), a multi-centre randomized trial with participating centres from The Netherlands, Finland, Sweden, Belgium, Italy, Portugal and Spain. The common core protocol includes enrolment at ages 55Ð69 and use of Hybritech Tandem-E PSA assay as the screening test with a cut-off level of 4.0 ng ml Ð1 . The primary end point is prostate cancer mortality, with quality of life and cost-effectiveness as the secondary end points.
MATERIALS AND METHODSIn the Finnish trial, the subjects are identified from the central population registry of Finland. Enrolment over 4 years with a total study population of 80 000 men is planned. The screening interval is 4 years and up to three screening rounds are planned. The primary end point is mortality from prostate cancer, which will be reported based on 10 years of follow-up from randomization.The study population of the trial consists of men born in 1929Ð1944 and resident in the metropolitan areas of Helsinki and Tampere. In the first year of the study (1996), 20 398 men born in 1929, 1933, 1937 or 1941 were randomized. The subjects were identified from the Population Registry of Finland. The only exclusion criterion was a previous diagnosis of prostate cancer. Information on prostate cancer was obtained through record linkage with the Finnish Cancer Registry. A total of 90 men were excluded before randomization because of previously diagnosed prostate cancer. Approximately 1% of the population (200 men of the eligible study population) has forbidden the use of their address information for any purposes and they were also excluded from randomization. Each year, 8000 men, i.e. approximately one third of the eligible population, are randomized to the screening arm and the rest to the control arm. Of the 8000 men, men who had died or moved out of the study area between the date of randomization (in early January) and date of invitation, were not invited to participate (n = 388 in 1996). Due to an error, additional 275 men were not invited in 1996. Men in the control group were not contacted, ...