Long-term Outcomes for Men in a Prostate Screening Trial with an Initial Benign Prostate Biopsy: A Population-based Cohort

Abstract

BackgroundThe optimal follow-up regimen for men after a benign prostate biopsy remains unknown. ObjectiveTo investigate long-term outcomes for men after an initial benign prostate biopsy. Design, setting, and participantsAll men with a benign biopsy in the first screening round of the Göteborg prostate cancer (PC) screening trial were included. The follow-up period was January 1, 1995–May 15, 2017. InterventionProstate-specific antigen (PSA) tests were performed every second year (upper median age limit 69yr). Men with PSA ≥3ng/ml underwent prostate biopsy (sextant biopsy up to 2009). Outcome measurements and statistical analysisThe 20-yr cumulative PC incidence and PC mortality were calculated using the 1 minus Kaplan-Meier method. Results and limitationsOf 452 men with a benign biopsy and followed for a median of 21.1yr, 169 were diagnosed with PC and five died from PC. The 20-yr cumulative PC incidence and PC mortality were 40.0% and 1.4%, respectively. The corresponding figures were 38.8% and 0.6% for men with initial PSA ≤10ng/ml, and 64.4% and 21.4% for PSA >10ng/ml. The proportion of men untreated at final follow-up was similar in the two PSA groups (22% vs 23%). The use of sextant biopsy for many years of the trial is a limitation. ConclusionsMen with an initial benign prostate biopsy run a very low risk of dying from PC when participating in a screening program. However, if followed for a long period, many men will be diagnosed and treated for PC. Low-intensity follow-up, as in the Göteborg trial, appears sufficient for men with PSA ≤10ng/ml after a benign biopsy. Patient summaryThis study shows that men who participate in a prostate cancer screening trial have a low risk of dying from prostate cancer if the first biopsy does not show cancer.