The Prognostic Value of Baseline PSA Density on Long-term Oncological Outcomes in Men with an Initial Negative Prostate Biopsy: Results from ERSPC Rotterdam.

Introduction: Baseline prostate-specific antigen (PSA) is associated with the risk of metastatic disease (M+) and prostate cancer (PCa)-specific mortality (PCSM). However, the prognostic value of baseline PSA density (PSA-D) for long-term oncological outcomes is less well established. This study aims to evaluate the prognostic value of baseline PSA-D for oncological outcomes in men who participated in a population-based screening study and had an elevated PSA but a negative prostate biopsy at their first screening visit. Material and methods: Data from the Rotterdam cohort of the European Randomized Study of Screening for Prostate Cancer (ERSPC) were used. All men aged 55-69 yr with PSA ≥ 3 ng/ml following a negative (sextant) biopsy at initial screening were included. Screening was repeated every 4 yr, with (repeat) biopsy if PSA ≥ 3 ng/ml. Screen-detected PCa was defined as PCa diagnosed during scheduled screening rounds. Men were stratified into three age groups according to the maximum number of potential screening rounds: 55-59, 60-64, and 65-69, and three baseline PSA-D groups reflecting clinical practice: <0.10, 0.10-0.15, and ≥0.15 ng/ml Results: In total, 1565 men met the inclusion criteria: 55-59 ( Conclusions: Baseline PSA-D is a useful tool for identifying a group of men at low risk of future oncological events after an initial negative biopsy. Although continued screening may have contributed to low CI of oncological outcomes, the limited number of screen-detected csPCa during follow-up screening rounds supports the use of baseline PSA-D for risk stratification and de-escalation of repeat testing. Men aged 55-59 with a baseline PSA-D < 0.10 ng/ml