[Results and participation factors to the European Randomized study of Screening for Prostate Cancer (ERSPC) with Prostate Specific Antigen: French departments of Tarn and Hérault].

INTRODUCTION: Mass screening modalities remained controversial and made necessary large studies. The European Randomized study of Screening for Prostate cancer (ERSPC) was initiated in 1994. Eight countries including France are participating.

METHODS: ERSPC is a multicentric randomised study and started with the aim to determine whether a 20% reduction in prostate cancer mortality can be achieved with PSA-based screening. Men aged 50-74 and living in the Tarn or Hérault were included. After randomization and exclusion of men who died or had a prostate cancer were invited to participate by giving their consent and had a PSA test. In case of PSA greater than or equal to 3 ng/ml, biopsy was recommended. Included men in both screening and control group were followed through cancer registries. Objective was to present first round results of French participation to ERSPC, to determine factors of participation and to compare detected cancers cases between both groups.

RESULTS: Population of men included was 84,781 and were randomized in screening (n=42,590) or control (n=42,191) group. Participation rate was 36.9% in Tarn and 24.3% in Hérault. PSA was greater than or equal to 3 ng/ml in 15,4% of cases (n=1812) and 45.9% of men (n=832) who were biopsied. Age, previous PSA performed within two years prior to invitation, health insurance and department of residence were significantly associated to participation rate. Cumulated incidence with a four years follow-up was 2.48% (n=1053) in screening and 1.99% (n=840) in control group, with a relative risk (RR) of 1.242. Corresponding RR for Tarn and Hérault were 1.37 and 1.20 respectively. Clinical parameters and treatments modalities were similar between both screening and control groups (radical prostatectomy 68% and radiation therapy 20%).

CONCLUSION: Participation rate at first round was modest. Profile of men who participated compared to men who did not were different. The control group was probably contaminated by PSA testing outside study protocol. Consequences at ERSPC level of this low participation rate on final analysis remain to be determined.