Results of the spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Update after 21 years of follow-up.

INTRODUCTION AND OBJECTIVE

The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) is to assess whether prostate cancer (PCa) screening leads to an improvement of cancer-specific survival. This multicenter study (eight European countries) has recruited more than 180,000 asymptomatic men. After a follow-up period of 16 years, it has been shown that PSA screening reduces PCa mortality by 20%, and that it does not affect all-cause mortality. This article provides updated the results of the Spanish arm of the ERSPC after 21 years of follow-up.

MATERIALS AND METHODS

The study invited 18,612 men (aged 45 - 70) of the Spanish section (Getafe and Parla, Madrid) to participate. They were randomly assigned to the intervention arm (serum PSA-based screening) and to the control arm (follow-up without intervention). The diagnoses of PCa were recorded, as well as the PCa-specific and all-cause mortality rates. A comparison between the survival curves of both arms of the study and detailed analysis of the causes of death were performed.

RESULTS

The study finally included 4,276 men (2,415 intervention arm, 1,861 control arm). The median age, serum PSA and follow-up time were 57 years, 0.9 ng/ml and 21.1 years, respectively. There were 285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p<,001). A total of 216 (75.8%) presented organ-confined disease. There were 994 deaths were recorded; 544 (22.5%) in the intervention arm and 450 (24.2%) in the control arm. No significant differences were detected between the arms of the study in terms of cancer-specific (p=.768) or all-cause (p=.192) mortality rates. The main cause of death was malignant tumors (492 patients, 49.5% of overall mortality), and the most frequent sites were lung and bronchus (29.5%), colon and rectum (14.8%), and hematologic (9.8%). Only 20 patients (0.4% of the patients recruited) died from PCa, with no significant difference between study arms.

CONCLUSIONS

In this update of the results of the Spanish section of the ERSPC study after 21 years of follow-up, we have not detected a benefit of PCa screening in terms of overall and cancer-specific survival.