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Randomized Controlled Trial
. 2014 Jun 10;110(12):2829-36.
doi: 10.1038/bjc.2014.242. Epub 2014 May 27.

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

E L Turner  1 , C Metcalfe  1 , J L Donovan  1 , S Noble  1 , J A C Sterne  1 , J A Lane  1 , K N Avery  1 , L Down  1 , E Walsh  1 , M Davis  1 , Y Ben-Shlomo  1 , S E Oliver  2 , S Evans  3 , P Brindle  4 , N J Williams  5 , L J Hughes  6 , E M Hill  1 , C Davies  1 , S Y Ng  7 , D E Neal  6 , F C Hamdy  8 , R M Martin  9 ; CAP trial group
Collaborators, Affiliations
Randomized Controlled Trial

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

E L Turner et al. Br J Cancer. .

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.

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Figures

Figure 1
Figure 1
Trial design.
Figure 2
Figure 2
Consort diagram for recruitment into the Cluster Randomised Trial of Testing for Prostate Cancer (CAP), England and Wales. aExplicit refusal=refused to participate. bImplicit refusal=no definitive response given to invitation to participate. cIncludes n=6581 pseudo-anonymised follow-up for mortality and prostate cancer. *Figures as of June 2013, subject to small changes over time because of continued updates from the Health and Social Care Information Centre, eg, to remove newly identified duplicates or changes to trace status.
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