Skip to content

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

Research output: Contribution to journalArticle

Standard

Effect of a Low-Intensity PSA-Based Screening Intervention on Prostate Cancer Mortality : The CAP Randomized Clinical Trial. / Martin, Richard; Donovan, Jenny; Turner, Emma; Metcalfe, Chris; Young, Grace; Walsh, Eleanor; Lane, J. Athene; Noble, Sian; Oliver, Steven; Evans, Simon; Sterne, Jonathan; Holding, Peter N; Ben-Shlomo, Yoav; Brindle, Peter; Williams, Naomi; Hill, Elizabeth; Ng, Siaw Yein; Davis, Jessica; Tazewell, Marta; Hughes, Laura J; Davies, Charlotte; Thorn, Joanna; Down, Liz; Davey Smith, George; Neal, David; Hamdy, Freddie; The CAP Trial Group.

In: JAMA - Journal of the American Medical Association, Vol. 319, No. 9, 06.03.2018, p. 883-895.

Research output: Contribution to journalArticle

Harvard

Martin, R, Donovan, J, Turner, E, Metcalfe, C, Young, G, Walsh, E, Lane, JA, Noble, S, Oliver, S, Evans, S, Sterne, J, Holding, PN, Ben-Shlomo, Y, Brindle, P, Williams, N, Hill, E, Ng, SY, Davis, J, Tazewell, M, Hughes, LJ, Davies, C, Thorn, J, Down, L, Davey Smith, G, Neal, D, Hamdy, F & The CAP Trial Group 2018, 'Effect of a Low-Intensity PSA-Based Screening Intervention on Prostate Cancer Mortality: The CAP Randomized Clinical Trial', JAMA - Journal of the American Medical Association, vol. 319, no. 9, pp. 883-895. https://doi.org/10.1001/jama.2018.0154

APA

Vancouver

Author

Martin, Richard ; Donovan, Jenny ; Turner, Emma ; Metcalfe, Chris ; Young, Grace ; Walsh, Eleanor ; Lane, J. Athene ; Noble, Sian ; Oliver, Steven ; Evans, Simon ; Sterne, Jonathan ; Holding, Peter N ; Ben-Shlomo, Yoav ; Brindle, Peter ; Williams, Naomi ; Hill, Elizabeth ; Ng, Siaw Yein ; Davis, Jessica ; Tazewell, Marta ; Hughes, Laura J ; Davies, Charlotte ; Thorn, Joanna ; Down, Liz ; Davey Smith, George ; Neal, David ; Hamdy, Freddie ; The CAP Trial Group. / Effect of a Low-Intensity PSA-Based Screening Intervention on Prostate Cancer Mortality : The CAP Randomized Clinical Trial. In: JAMA - Journal of the American Medical Association. 2018 ; Vol. 319, No. 9. pp. 883-895.

Bibtex

@article{c8feb71124d1499ebee10ebff94d84a2,
title = "Effect of a Low-Intensity PSA-Based Screening Intervention on Prostate Cancer Mortality: The CAP Randomized Clinical Trial",
abstract = "Importance: Prostate-cancer screening remains controversial because of concerns that potential mortality or quality of life benefits are outweighed by harms from over-detection and subsequent over-treatment. Objective: To evaluate the effect of a low-intensity, single PSA screening intervention and standardized diagnostic pathway on prostate cancer specific mortality.Design, Setting, Participants: Cluster-randomized clinical trial conducted in 573 general practices (the clusters) across the UK and including 419,582 men aged 50-69 who were randomized between 2001 and 2009. Follow-up was completed March 31, 2016.Intervention: An invitation to a single PSA-test versus standard (unscreened) practice. Main outcome and measures: Primary outcome: prostate cancer mortality at a median of 10-years’ follow-up, analyzed by intention-to-screen. Pre-specified secondary outcomes: diagnostic stage and grade of prostate cancers identified, all-cause mortality and instrumental variable analysis estimating the causal effect of attending PSA screening. Results: Among 415,357 eligible men who were randomized (mean age, 59.0 years), 189,386 men in the intervention-group and 219,439 controls were included in the analysis (n=408,825, 98{\%}). In the intervention-group, 75,707 (40{\%}) attended PSA-testing and 6,857 (4{\%}) had a PSA ≥3-<20ng/ml, of whom 5,850 (85{\%}) had a prostate biopsy. After a median follow-up of 10-years, 549 (0.30 per 1000-person years) men had died from prostate cancer in the intervention group compared with 647 (0.31 per 1000-person years) in the control-group (rate difference -0.013 per 1000-person years, 95{\%}CI -0.047, 0.02; rate-ratio [RR] 0.96, 95{\%}CI 0.85,1.08; p=0.50). The number of prostate cancers diagnosed was higher in the intervention-group (n=8,054; 4.3{\%}) than control-group (n=7,853; 3.6{\%}) (RR 1.19, 95{\%}CI 1.14,1.25; p<0.001). More Gleason grade ≤6 tumors were identified in the intervention than control groups (n=3,263/189,386 [1.7{\%}] vs. n=2,440/219,439 [1.1{\%}]; difference per 1000 = 6.11, 95{\%} CI 5.38, 6.84; p<0.001). In the analysis of all-cause mortality, there were 25,459 deaths in the intervention group, and 28,306 deaths in the control group (RR 0.99, 95{\%}CI 0.94,1.03; p=0.49). In instrumental variable analysis, the adherence-adjusted causal RR for prostate cancer mortality was 0.93 (95{\%}CI 0.67,1.29; p=0.66). Conclusion and relevance: Among practices randomized to a low-intensity PSA screening intervention compared with standard practice, there was no significant difference in prostate cancer mortality after a median 10-years follow up, but the detection of low-risk prostate cancers increased. Although longer-term follow-up is in progress, the current findings do not support single PSA-testing for population-based screening. Current Controlled Trials number: ISRCTN92187251.",
author = "Richard Martin and Jenny Donovan and Emma Turner and Chris Metcalfe and Grace Young and Eleanor Walsh and Lane, {J. Athene} and Sian Noble and Steven Oliver and Simon Evans and Jonathan Sterne and Holding, {Peter N} and Yoav Ben-Shlomo and Peter Brindle and Naomi Williams and Elizabeth Hill and Ng, {Siaw Yein} and Jessica Davis and Marta Tazewell and Hughes, {Laura J} and Charlotte Davies and Joanna Thorn and Liz Down and {Davey Smith}, George and David Neal and Freddie Hamdy and {The CAP Trial Group}",
year = "2018",
month = "3",
day = "6",
doi = "10.1001/jama.2018.0154",
language = "English",
volume = "319",
pages = "883--895",
journal = "JAMA - Journal of the American Medical Association",
issn = "0098-7484",
publisher = "American Medical Association",
number = "9",

}

RIS - suitable for import to EndNote

TY - JOUR

T1 - Effect of a Low-Intensity PSA-Based Screening Intervention on Prostate Cancer Mortality

T2 - The CAP Randomized Clinical Trial

AU - Martin, Richard

AU - Donovan, Jenny

AU - Turner, Emma

AU - Metcalfe, Chris

AU - Young, Grace

AU - Walsh, Eleanor

AU - Lane, J. Athene

AU - Noble, Sian

AU - Oliver, Steven

AU - Evans, Simon

AU - Sterne, Jonathan

AU - Holding, Peter N

AU - Ben-Shlomo, Yoav

AU - Brindle, Peter

AU - Williams, Naomi

AU - Hill, Elizabeth

AU - Ng, Siaw Yein

AU - Davis, Jessica

AU - Tazewell, Marta

AU - Hughes, Laura J

AU - Davies, Charlotte

AU - Thorn, Joanna

AU - Down, Liz

AU - Davey Smith, George

AU - Neal, David

AU - Hamdy, Freddie

AU - The CAP Trial Group

PY - 2018/3/6

Y1 - 2018/3/6

N2 - Importance: Prostate-cancer screening remains controversial because of concerns that potential mortality or quality of life benefits are outweighed by harms from over-detection and subsequent over-treatment. Objective: To evaluate the effect of a low-intensity, single PSA screening intervention and standardized diagnostic pathway on prostate cancer specific mortality.Design, Setting, Participants: Cluster-randomized clinical trial conducted in 573 general practices (the clusters) across the UK and including 419,582 men aged 50-69 who were randomized between 2001 and 2009. Follow-up was completed March 31, 2016.Intervention: An invitation to a single PSA-test versus standard (unscreened) practice. Main outcome and measures: Primary outcome: prostate cancer mortality at a median of 10-years’ follow-up, analyzed by intention-to-screen. Pre-specified secondary outcomes: diagnostic stage and grade of prostate cancers identified, all-cause mortality and instrumental variable analysis estimating the causal effect of attending PSA screening. Results: Among 415,357 eligible men who were randomized (mean age, 59.0 years), 189,386 men in the intervention-group and 219,439 controls were included in the analysis (n=408,825, 98%). In the intervention-group, 75,707 (40%) attended PSA-testing and 6,857 (4%) had a PSA ≥3-<20ng/ml, of whom 5,850 (85%) had a prostate biopsy. After a median follow-up of 10-years, 549 (0.30 per 1000-person years) men had died from prostate cancer in the intervention group compared with 647 (0.31 per 1000-person years) in the control-group (rate difference -0.013 per 1000-person years, 95%CI -0.047, 0.02; rate-ratio [RR] 0.96, 95%CI 0.85,1.08; p=0.50). The number of prostate cancers diagnosed was higher in the intervention-group (n=8,054; 4.3%) than control-group (n=7,853; 3.6%) (RR 1.19, 95%CI 1.14,1.25; p<0.001). More Gleason grade ≤6 tumors were identified in the intervention than control groups (n=3,263/189,386 [1.7%] vs. n=2,440/219,439 [1.1%]; difference per 1000 = 6.11, 95% CI 5.38, 6.84; p<0.001). In the analysis of all-cause mortality, there were 25,459 deaths in the intervention group, and 28,306 deaths in the control group (RR 0.99, 95%CI 0.94,1.03; p=0.49). In instrumental variable analysis, the adherence-adjusted causal RR for prostate cancer mortality was 0.93 (95%CI 0.67,1.29; p=0.66). Conclusion and relevance: Among practices randomized to a low-intensity PSA screening intervention compared with standard practice, there was no significant difference in prostate cancer mortality after a median 10-years follow up, but the detection of low-risk prostate cancers increased. Although longer-term follow-up is in progress, the current findings do not support single PSA-testing for population-based screening. Current Controlled Trials number: ISRCTN92187251.

AB - Importance: Prostate-cancer screening remains controversial because of concerns that potential mortality or quality of life benefits are outweighed by harms from over-detection and subsequent over-treatment. Objective: To evaluate the effect of a low-intensity, single PSA screening intervention and standardized diagnostic pathway on prostate cancer specific mortality.Design, Setting, Participants: Cluster-randomized clinical trial conducted in 573 general practices (the clusters) across the UK and including 419,582 men aged 50-69 who were randomized between 2001 and 2009. Follow-up was completed March 31, 2016.Intervention: An invitation to a single PSA-test versus standard (unscreened) practice. Main outcome and measures: Primary outcome: prostate cancer mortality at a median of 10-years’ follow-up, analyzed by intention-to-screen. Pre-specified secondary outcomes: diagnostic stage and grade of prostate cancers identified, all-cause mortality and instrumental variable analysis estimating the causal effect of attending PSA screening. Results: Among 415,357 eligible men who were randomized (mean age, 59.0 years), 189,386 men in the intervention-group and 219,439 controls were included in the analysis (n=408,825, 98%). In the intervention-group, 75,707 (40%) attended PSA-testing and 6,857 (4%) had a PSA ≥3-<20ng/ml, of whom 5,850 (85%) had a prostate biopsy. After a median follow-up of 10-years, 549 (0.30 per 1000-person years) men had died from prostate cancer in the intervention group compared with 647 (0.31 per 1000-person years) in the control-group (rate difference -0.013 per 1000-person years, 95%CI -0.047, 0.02; rate-ratio [RR] 0.96, 95%CI 0.85,1.08; p=0.50). The number of prostate cancers diagnosed was higher in the intervention-group (n=8,054; 4.3%) than control-group (n=7,853; 3.6%) (RR 1.19, 95%CI 1.14,1.25; p<0.001). More Gleason grade ≤6 tumors were identified in the intervention than control groups (n=3,263/189,386 [1.7%] vs. n=2,440/219,439 [1.1%]; difference per 1000 = 6.11, 95% CI 5.38, 6.84; p<0.001). In the analysis of all-cause mortality, there were 25,459 deaths in the intervention group, and 28,306 deaths in the control group (RR 0.99, 95%CI 0.94,1.03; p=0.49). In instrumental variable analysis, the adherence-adjusted causal RR for prostate cancer mortality was 0.93 (95%CI 0.67,1.29; p=0.66). Conclusion and relevance: Among practices randomized to a low-intensity PSA screening intervention compared with standard practice, there was no significant difference in prostate cancer mortality after a median 10-years follow up, but the detection of low-risk prostate cancers increased. Although longer-term follow-up is in progress, the current findings do not support single PSA-testing for population-based screening. Current Controlled Trials number: ISRCTN92187251.

UR - http://www.scopus.com/inward/record.url?scp=85043284113&partnerID=8YFLogxK

U2 - 10.1001/jama.2018.0154

DO - 10.1001/jama.2018.0154

M3 - Article

VL - 319

SP - 883

EP - 895

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0098-7484

IS - 9

ER -