PD11-06: Baseline PSA below 1.0 ng/ml, and then? Verification of the EAU 2021 Position and Recommendation on risk-adapted early detection using ERSPC Rotterdam data with more than 20 years of detailed follow-up.
Introduction: The ERSPC and other population-based prostate cancer (PCa) trials show unambiguously that a baseline PSA is indicative for the risk of developing (life-threatening) PCa in the decade(s) to come. This has important implications for further testing and it is therefore that most guidelines now recommend a follow-up algorithm based on baseline PSA. The recently published EAU 2021 Position paper suggests in men with low baseline PSA, to apply a 5-year retesting interval or stopping rule for different age groups (fig 1). Here we validate these recommendations on ERSPC Rotterdam data with a detailed follow-up of 20-26 years after baseline PSA.
Methods: A total of 16,586 men, aged 55-69 years, were randomized to a 4-year screening protocol in the period 1993-1999. We collected and analyzed detailed incidence and mortality data up to 01-01-2020 of those men that had a baseline PSA of <1.0 ng/ml aged 54-59 (A) and 60-69 yr (B).
Results: Of the 16,586 men randomized, 6344 men (38%) had a baseline PSA <1.0 ng/ml (3027 in group A and 3317 in group B). A total of 285 (4.5%) men were diagnosed with PCa (6.0% in A and 3.1% in B), after a median follow-up of 13.5 yr (A) and 11.1 yr (B; tab 1). In both groups the time from initial PSA to a diagnosis of csPCa was 2-3 times longer than the proposed re-screening interval of 5 yr. Data on PCa grading showed that most detected PCa are Gleason 6 PCa (fig 2). In total, 21 PCa cases (0.3%) were M+ at time of diagnosis which occurred more than 15 yrs after baseline PSA. 18 PCa progressed to M+ disease (6.3% of all PCa) 5 yr after diagnosis. M+ disease is more common in group B (22% of all PCa, group A 8.8%). With a median FU of 21 yr, 34.4% of men in A and 61.8% in B have died. PCa mortality is rare; 0.26% in A and 0.45% in B. Diagnoses, progression and death occur at least 10-15 yr after baseline PSA (tab 1, fig 3).
Conclusions: Although there is a possibility for men aged >54 yr and a baseline PSA level <1.0 ng/ml to be confronted with a diagnosis, to suffer from M+ disease and to die from PCa, the risk is very low within a time frame of 2 decades. The recommended 5 year interval for retesting or even stopping screening in elderly men seems justified when taking into account the considerable harm that coincides with repeated screenings at an elderly age.