The performance of tests outside prostate cancer screening trials (PSA contamination) may affect their statistical power. The present study addressed the extent of PSA contamination in the Spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC) and its impact on biopsy performance and prostate cancer detection.
Data linkage was performed to address screening-related interventions outside the study. Four databases were used: (1) Spanish ERSPC database (n
Median follow-up time was 6.6 yr. A total of 2201 PSA determinations were performed for 1253 men. Cumulative PSA contamination was 29.3% (17% in the control arm during the first 4 yr). A higher proportion of men undergoing biopsies was found in the screening arm (21.3% vs. 2.9% in the control arm, p
In our experience, the PSA contamination rate has increased during the last years, but its impact on biopsy performance and cancer detection in the control arm of the trial is limited and not likely to compromise the statistical power of the ERSPC trial.
Keywords: Mass screening, Prostatic neoplasms, Prostate-specific antigen.
a Urology Department, Hospital Universitario de Getafe, Madrid, Spain
b Urology Department, Hospital de Fuenlabrada, Madrid, Spain
c Biochemistry Department, Hospital Universitario de Getafe, Madrid, Spain
© 2006 European Association of Urology, Published by Elsevier B.V.