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PLoS One. 2019 Nov 5;14(11):e0224479. doi: 10.1371/journal.pone.0224479. eCollection 2019.

Cost-effectiveness analysis of PSA-based mass screening: Evidence from a randomised controlled trial combined with register data.

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Faculty of Social Sciences (Health Sciences), Tampere University, Tampere, Finland.
Department of Urology, Tampere University Hospital, Tampere, Finland.
Faculty of Medicine and Life Sciences, Tampere University, Tampere, Finland.
Department of Pathology, Fimlab Laboratories, Tampere, Finland.
Department of Clinical Chemistry and Haematology, University of Helsinki, Helsinki, Finland.
Department of Urology, University of Helsinki, Helsinki, Finland.
Finnish Cancer Registry, Helsinki, Finland.


In contrast to earlier studies which have used modelling to perform cost-effectiveness analysis, this study links data from a randomised controlled trial with register data from nationwide registries to reveal new evidence on costs, effectiveness, and cost-effectiveness of organised mass prostate-cancer screening based on prostate-specific antigen (PSA) testing. Cost-effectiveness analyses were conducted with individual-level data on health-care costs from comprehensive registers and register data on real-world effectiveness from the two arms of the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC), following 80,149 men from 1996 through 2015. The study examines cost-effectiveness in terms of overall mortality and, in addition, in terms of diagnosed men's mortality from prostate cancer and mortality with but not from prostate cancer. Neither arm of the FinRSPC was clearly more cost-effective in analysis in terms of overall mortality. Organised screening in the FinRSPC could be considered cost-effective in terms of deaths from prostate cancer: averting just over one death per 1000 men screened. However, even with an estimated incremental cost-effectiveness ratio of below 20,000€ per death avoided, this result should not be considered in isolation. This is because mass screening in this trial also resulted in increases in death with, but not from, prostate cancer: with over five additional deaths per 1000 men screened. Analysis of real-world data from the FinRSPC reveals new evidence of the comparative effectiveness of PSA-based screening after 20 years of follow-up, suggesting the possibility of higher mortality, as well as higher healthcare costs, for screening-arm men who have been diagnosed with prostate cancer but who do not die from it. These findings should be corroborated or contradicted by similar analyses using data from other trials, in order to reveal if more diagnosed men have also died in the screening arms of other trials of mass screening for prostate cancer.

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Conflict of interest statement

PK has taken part in a conference with support from Amgen. Fimlab Laboratories provided support in the form of a salary for PK, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. TT has acted as a consultant for Orion Pharma, Bayer AG, and Ferring and received research funding from Medivation, Pfizer, and Lidds AB. KT has taken part in a conference with support from Astellas and received research funding from Medivation, Astellas, and Pfizer. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

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