Population based screening for prostate cancer : tumor characteristics

Abstract

The European Randomized study of Screening for Prostate Cancer is a multi-centre randomized controlled trial to examine whether screening for prostate cancer has an effect on prostate cancer mortality. The total study cohort consists of 268.000 men in eight different European Countries. In the Netherlands the study is being conducted in the region of Rotterdam by the study group of the Erasmus Medical Centre Rotterdam. Between 1993 and 2000 a total of 42,376 men (21,210 in the screen arm and 21,166 in the control arm) aged 55-74 years were randomized to the ERSPC, section Rotterdam. In the screen arm screening consisted of PSA measurement, rectal examination and trans-rectal ultrasound. From December 1993 to February 1997 the Rotterdam screening regimen called for lateralized sextant trans-rectal biopsy if the PSA level was equal to or higher than 4.0 ng/ml, and if ORE and/or TRUS were suspicious for cancer at low PSA values (0.0 - 3.9 ng/ml). The biopsy procedure was performed in a second visit. From December 1993 to October 1996 an early recall visit (after one year) was performed for those men who had a biopsy indication in the prevalence screen but a negative biopsy outcome. These men were invited again for PSA, DRE, TRUS and sextant biopsy. From February 1997 onwards, a PSA of ~ 3.0 ng/ml became the sole biopsy indication. The ERSPC, section Rotterdam applies a re-screening interval of 4 years. Men in the control arm were not offered PSA measurement or screening. They received general medical health care.