Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP)

E. L. Turner, C. Metcalfe, J. L. Donovan, S. Noble, J. A.C. Sterne, J. A. Lane, K. N. Avery, L. Down, E. Walsh, M. Davis, Y. Ben-Shlomo, S. E. Oliver, S. Evans, P. Brindle, N. J. Williams, L. J. Hughes, E. M. Hill, C. Davies, S. Y. Ng, D. E. NealF. C. Hamdy, R. M. Martin

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

Abstract

Background:Screening for prostate cancer continues to generate controversy because of concerns about over-diagnosis and unnecessary treatment. We describe the rationale, design and recruitment of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP) trial, a UK-wide cluster randomised controlled trial investigating the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing.Methods:Seven hundred and eighty-five general practitioner (GP) practices in England and Wales were randomised to a population-based PSA testing or standard care and then approached for consent to participate. In the intervention arm, men aged 50-69 years were invited to undergo PSA testing, and those diagnosed with localised prostate cancer were invited into a treatment trial. Control arm practices undertook standard UK management. All men were flagged with the Health and Social Care Information Centre for deaths and cancer registrations. The primary outcome is prostate cancer mortality at a median 10-year-follow-up.Results:Among randomised practices, 271 (68%) in the intervention arm (198 114 men) and 302 (78%) in the control arm (221 929 men) consented to participate, meeting pre-specified power requirements. There was little evidence of differences between trial arms in measured baseline characteristics of the consenting GP practices (or men within those practices).Conclusions:The CAP trial successfully met its recruitment targets and will make an important contribution to international understanding of PSA-based prostate cancer screening.

Original languageEnglish
Pages (from-to)2829-2836
Number of pages8
JournalBritish Journal of Cancer
Volume110
Issue number12
DOIs
StatePublished - Jun 10 2014
Externally publishedYes

Keywords

  • Cluster randomised controlled trial
  • Cost-effectiveness
  • Prostate cancer
  • Prostate cancer mortality
  • Prostate-specific antigen
  • Screening

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