Background: The European Randomised Study of Screening for Prostate Cancer (ERSPC) applies a prostate-specific antigen (PSA) cut-off value >= 3.0 ng/ml as an indication for lateralised sextant biopsy. Objective: To analyse the incidence and disease-specific mortality for prostate cancer (PCa) in men with an initial PSA < 3.0 ng/ml. Design, setting and participants: From November 1993 to December 1999, a total of 42 376 men identified from population registries in the Rotterdam region (55-74 yr of age) were randomised to an intervention or control arm. A total of 19 950 men were screened during the first screening round. Intervention: A PSA < 3.0 ng/ml was below the biopsy threshold. PCa cases were identified at rescreens every 4 yr or as interval cancers. Measurements: Distribution of incidence, aggressiveness, and disease-specific mortality of PCa per PSA range was measured. Causes of death were evaluated by an independent committee, and follow-up was complete until 31 December 2008. Results and limitations: From 1993 to 2008, 915 PCa cases were diagnosed in 15 758 men (5.8%) with an initial PSA < 3.0 ng/ml and a median age of 62.3 yr. Median overall follow-up was 11 yr. PCa incidence increased significantly with higher initial PSA levels. Aggressive PCa (clinical stage >= T2c, Gleason score >= 8, PSA > 20 ng/ml, positive lymph nodes, or metastases at diagnosis) was detected in 66 of 733 screen-detected PCa cases (9.0%) and 72 of 182 interval-detected PCa cases (39.6%). Twenty-three PCa deaths occurred in the total population (0.15%), with an increasing risk of PCa mortality in men with higher initial PSA values. Conclusions: The risk of PCa, aggressive PCa and PCa mortality in a screening population with initial PSA < 3.0 ng/ml increases significantly with higher initial PSA levels. These results contribute to the risk stratification and individual management of men in PSA-based screening programmes. (C) 2011 European Association of Urology. Published by Elsevier B. V. All rights reserved.