Periodic PSA-based screening in men 55 to 69 years of age reduced prostate cancer mortality

Abstract

Question: In men 55 to 69 years of age, does periodic prostate-specific antigen (PSA)-based screening reduce risk for prostate cancer mortality? Methods Design: Randomized controlled trial (European Randomized Study of Screening for Prostate Cancer [ERSPC]). Current Controlled Trials ISRCTN49127736. Allocation: {Concealed}*.† Blinding: Blinded† (cause of death evaluation). Follow-up period: Median 11 years. Setting: The Netherlands, Belgium, Sweden, Finland, Italy, Spain, and Switzerland. Data from France (n = 79 014) were not included because of short follow-up (median 4.6 y). Participants: 162 388 men in the predefined core age group (55 to 69 y, {mean age 61 y}‡). {Men with a previous diagnosis of prostate cancer were excluded}‡. 19 772 men who were outside of the core age group were not included in this analysis. Intervention: PSA-based screening for prostate cancer every 2 to 4 years (median 4 y) (n = 72 891) or usual care (n = 89 352). In most centers, positive PSA tests (serum level ≥ 3.0 ng/mL) were an indication for biopsy. Outcomes: Primary outcome was prostate cancer mortality. Other reported outcomes included prostate cancer incidence and all-cause mortality. Participant follow-up: 99.9% were included in the intention-to-screen analysis. Main results: In the screening group, 83% of men were screened at least once, 17% of PSA tests were positive, and 86% of positive tests were followed by biopsy. Screening increased risk for diagnosis of prostate cancer and reduced risk for prostate cancer mortality compared with usual care; groups did not differ for all-cause mortality (Table). To prevent 1 death from prostate cancer, 936 men would have to be invited to screening (NNI) and 33 cancers would need to be detected (NND). Conclusion: In men 55 to 69 years of age, prostate-specific antigen-based screening reduced prostate cancer mortality. © 2012 American College of Physicians.