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.
Written by:
Turner EL, Metcalfe C, Donovan JL, Noble S, Sterne JA, Lane JA, Avery KN, Down L, Walsh E, Davis M, Ben-Shlomo Y, Oliver SE, Evans S, Brindle P, Williams NJ, Hughes LJ, Hill EM, Davies C, Ng SY, Neal DE, Hamdy FC, Martin RM. Are you the author?
School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK; Department of Health Sciences, University of York and the Hull York Medical School, York YO10 5DD, UK; Royal United Hospital Bath, Combe Park, Bath BA1 3NG, UK; Avon Primary Care Research Collaborative, Marlborough Street, South Plaza, Bristol BS1 3NX, UK; School of Social and Community Medicine, University of Bristol, Royal Hallamshire Hospital, Sheffield S10 2JF, UK; Department of Oncology, University of Cambridge, Box 279 (S4), Addenbrooke's Hospital, Cambridge CB2 0QQ, UK; School of Social and Community Medicine, University of Bristol, Freeman Hospital, High Heaton, Newcastle upon Tyne NE7 7DN, UK; Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford OX3 9DU, UK; MRC/University of Bristol Integrative Epidemiology Unit, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK.
Reference: Br J Cancer. 2014 Jun 10;110(12):2829-36.
doi: 10.1038/bjc.2014.242
PubMed Abstract
PMID: 24867688
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