Design and Preliminary Recruitment Results of the Cluster Randomised TriAl of PSA Testing for Prostate Cancer (CAP)

Overview

Journal Br J Cancer

Specialty Oncology

Date 2014 May 29

PMID 24867688

Citations 16

Authors

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 Neal

F C Hamdy

R M Martin

Affiliations

Soon will be listed here.

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.

Citing Articles

Impact of PSA testing on secondary care costs in England and Wales: estimates from the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

Thorn J, Turner E, Walsh E, Donovan J, Neal D, Hamdy F BMC Health Serv Res. 2023; 23(1):610.

PMID: 37296430 PMC: 10257301. DOI: 10.1186/s12913-023-09503-7.

UPDATE - 2022 Canadian Urological Association recommendations on prostate cancer screening and early diagnosis Endorsement of the 2021 Cancer Care Ontario guidelines on prostate multiparametric magnetic resonance imaging.

Mason R, Marzouk K, Finelli A, Saad F, So A, Violette P Can Urol Assoc J. 2022; 16(4):E184-E196.

PMID: 35358414 PMC: 9054332. DOI: 10.5489/cuaj.7851.

Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT.

Hamdy F, Donovan J, Athene Lane J, Mason M, Metcalfe C, Holding P Health Technol Assess. 2020; 24(37):1-176.

PMID: 32773013 PMC: 7443739. DOI: 10.3310/hta24370.

Effect of a Low-Intensity PSA-Based Screening Intervention on Prostate Cancer Mortality: The CAP Randomized Clinical Trial.

Martin R, Donovan J, Turner E, Metcalfe C, Young G, Walsh E JAMA. 2018; 319(9):883-895.

PMID: 29509864 PMC: 5885905. DOI: 10.1001/jama.2018.0154.

Recommandations de l'Association des urologues du Canada sur le dépistage et le diagnostic précoce du cancer de la prostate.

Rendon R, Mason R, Marzouk K, Finelli A, Saad F, So A Can Urol Assoc J. 2018; 11(10):298-309.

PMID: 29381452 PMC: 5659858. DOI: 10.5489/cuaj.4888.

References

de Koning H, Liem M, Baan C, Boer R, Schroder F, Alexander F . Prostate cancer mortality reduction by screening: power and time frame with complete enrollment in the European Randomised Screening for Prostate Cancer (ERSPC) trial. Int J Cancer. 2002; 98(2):268-73. DOI: 10.1002/ijc.10188. View

Miller A, Yurgalevitch S, Weissfeld J . Death review process in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Control Clin Trials. 2001; 21(6 Suppl):400S-406S. DOI: 10.1016/s0197-2456(00)00095-7. View

Thompson I, Pauler D, Goodman P, Tangen C, Lucia M, Parnes H . Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter. N Engl J Med. 2004; 350(22):2239-46. DOI: 10.1056/NEJMoa031918. View

Gulati R, Mariotto A, Chen S, Gore J, Etzioni R . Long-term projections of the harm-benefit trade-off in prostate cancer screening are more favorable than previous short-term estimates. J Clin Epidemiol. 2011; 64(12):1412-7. PMC: 3517213. DOI: 10.1016/j.jclinepi.2011.06.011. View

McNaughton-Collins M, Barry M . One man at a time--resolving the PSA controversy. N Engl J Med. 2011; 365(21):1951-3. DOI: 10.1056/NEJMp1111894. View

Ilic D, OConnor D, Green S, Wilt T . Screening for prostate cancer: an updated Cochrane systematic review. BJU Int. 2011; 107(6):882-91. DOI: 10.1111/j.1464-410X.2010.10032.x. View

Lane J, Hamdy F, Martin R, Turner E, Neal D, Donovan J . Latest results from the UK trials evaluating prostate cancer screening and treatment: the CAP and ProtecT studies. Eur J Cancer. 2010; 46(17):3095-101. DOI: 10.1016/j.ejca.2010.09.016. View

Black W, Haggstrom D, Welch H . All-cause mortality in randomized trials of cancer screening. J Natl Cancer Inst. 2002; 94(3):167-73. DOI: 10.1093/jnci/94.3.167. View

Donovan J . Presenting treatment options to men with clinically localized prostate cancer: the acceptability of active surveillance/monitoring. J Natl Cancer Inst Monogr. 2012; 2012(45):191-6. PMC: 3540874. DOI: 10.1093/jncimonographs/lgs030. View

10.

Brett A, Ablin R . Prostate-cancer screening--what the U.S. Preventive Services Task Force left out. N Engl J Med. 2011; 365(21):1949-51. DOI: 10.1056/NEJMp1112191. View

11.

Donovan J, Hamdy F, Neal D, Peters T, Oliver S, Brindle L . Prostate Testing for Cancer and Treatment (ProtecT) feasibility study. Health Technol Assess. 2003; 7(14):1-88. DOI: 10.3310/hta7140. View

12.

Albertsen P, Walters S, Hanley J . A comparison of cause of death determination in men previously diagnosed with prostate cancer who died in 1985 or 1995. J Urol. 2000; 163(2):519-23. View

13.

Down L, Metcalfe C, Avery K, Noble S, Athene Lane J, Neal D . Factors distinguishing general practitioners who more readily participated in a large randomized trial were identified. J Clin Epidemiol. 2008; 62(1):67-73. DOI: 10.1016/j.jclinepi.2008.02.014. View

14.

Holmstrom B, Johansson M, Bergh A, Stenman U, Hallmans G, Stattin P . Prostate specific antigen for early detection of prostate cancer: longitudinal study. BMJ. 2009; 339:b3537. PMC: 2751815. DOI: 10.1136/bmj.b3537. View

15.

Frankel S, Davey Smith G, Donovan J, Neal D . Screening for prostate cancer. Lancet. 2003; 361(9363):1122-8. DOI: 10.1016/S0140-6736(03)12890-5. View

16.

Andriole G, Crawford E, Grubb 3rd R, Buys S, Chia D, Church T . Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009; 360(13):1310-9. PMC: 2944770. DOI: 10.1056/NEJMoa0810696. View

17.

Wilt T . The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with.... J Natl Cancer Inst Monogr. 2012; 2012(45):184-90. PMC: 3540866. DOI: 10.1093/jncimonographs/lgs041. View

18.

Auvinen A, Rietbergen J, Denis L, Schroder F, Prorok P . Prospective evaluation plan for randomised trials of prostate cancer screening. The International Prostate Cancer Screening Trial Evaluation Group. J Med Screen. 1996; 3(2):97-104. DOI: 10.1177/096914139600300211. View

19.

Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T . Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be.... BMJ. 2002; 325(7367):766-70. PMC: 1124277. DOI: 10.1136/bmj.325.7367.766. View

20.

Cuzick J, Edwards R, Segnan N . Adjusting for non-compliance and contamination in randomized clinical trials. Stat Med. 1997; 16(9):1017-29. DOI: 10.1002/(sici)1097-0258(19970515)16:9<1017::aid-sim508>3.0.co;2-v. View