Articles

Prostate Cancer

Extent of Prostate-Specific Antigen Contamination in the Spanish Section of the European Randomized Study of Screening for Prostate Cancer (ERSPC)

By: Marcos Lujána lowast , Alvaro Páezb, Carlos Pascuala, Javier Anguloa, Elena Miravallesc and Antonio Berenguera

European Urology, Volume 50 Issue 1, December 2006, Pages 1234-1240

Published online: 01 December 2006

Keywords: Mass screening, Prostatic neoplasms, Prostate-specific antigen

Abstract Full Text Full Text PDF (394 KB)

Abstract

Objectives

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.

Methods

Data linkage was performed to address screening-related interventions outside the study. Four databases were used: (1) Spanish ERSPC database (n=4278), (2) laboratory database with all PSA determinations (n=31,140), (3) database of 1608 prostate biopsies, and (4) records of all prostate cancers (n=819) diagnosed at our centre. PSA contamination, biopsy performance, and cancer detection rates were calculated.

Results

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<0.0001). Similarly, higher cancer detection rates were found in the screening (4.7% vs. 1.2% in the control arm, p<0.0001).

Conclusions

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.

Take Home Message

PSA contamination (opportunistic PSA testing) is supposed to be a potential threat for prostate cancer screening clinical trials. We attempt to quantify this phenomenon and to analyse its impact in terms of biopsy performance and cancer detection.

Keywords: Mass screening, Prostatic neoplasms, Prostate-specific antigen.

Footnotes

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

lowast Corresponding author. Hospital Universitario de Getafe, Servicio de Urología, Ctra Toledo km 12,500 Getafe, 28905 Madrid, Spain. Tel. +34 91 6833271; Fax: +34 91 6833271.

Place a comment

Your comment *

max length: 5000