Specific features of the Italian section of the ERSPC

1 Randomization: subjects are randomized before informed consent. An updated residence database is currently available from the Florence municipality. The whole target resident population has been randomized, not only consenting volunteers. This is a difference from most ERSPC active centres adopting randomization of consenting volunteers 2 The criteria prompting a diagnostic assessment. (i) the PSA threshold for sextant random biopsy remained at 4 ng/mL, as in the original ERSPC protocol, whereas in other ERSPC active centres the threshold was reduced to 3 ng/mL. (ii) a PSA level of ≥ 2.5 ng/ mL prompts a DRE and TRUS, with a directed biopsy of any DRE and TRUS abnormalities in the 2.5–4 ng/mL PSA range. The 2.5 ng/mL threshold was adopted, as all cancers detected in the original pilot studied were within this PSA limit [4]. 3 Biopsy technique: the biopsy approach is transperineal rather than transrectal, as in all other ERSPC active centres. An ERSPC study showed that the transperineal approach is not inferior, but possibly superior to the transrectal as far as sensitivity is concerned [5].