Effects of modified inclusion criteria and negative reporting about PSA screening on the number of potentially recruitable patients for the PREFERE study

BACKGROUND: The PREFERE study is currently below expectations. The objective of this study was to investigate the effect of the modification of the inclusion criteria in 2015 on the number of recruitable patients with localized prostate cancer. Furthermore we analyzed whether fewer cases of low-risk prostate cancer were detected in 2014 than in 2010. PATIENTS AND METHODS: Prostate biopsies of 2136 patients (9 hospitals) of the years 2010 and 2014 were retrospectively reviewed, regarding the eligibility for participation in the PREFERE study. RESULTS: According to PREFERE criteria version 3.2, 16.8 % (in 2010) and 16.7 % (in 2014) of the patients fulfilled the inclusion criteria for the study, whereas 41.9 % (in 2010) and 30.1 % (in 2014) of the patients met the criteria in version 5.0. CONCLUSIONS: Our results indicate that the modified inclusion criteria result in an increase in the number of recruitable patients for the PREFERE study. Furthermore, there were 11.8 % fewer cases of potentially recruitable patients in 2014 than in 2010 by use of version 5.0. This is a possible indication for an altered use of prostate biopsy.