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ISRCTN
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ISRCTN92187251
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DOI
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10.1186/ISRCTN92187251
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Evaluating population-based screening for localised prostate cancer in the United Kingdom: an extension to the ProtecT treatment trial
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Scientific title
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Evaluating population-based screening for localised prostate cancer in the United Kingdom: a randomised controlled extension to the ProtecT treatment trial
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Acronym
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The CAP (Comparison Arm for ProtecT) study
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Serial number at source
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N/A
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Study hypothesis
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The hypothesis under investigation is that population screening in the form of prostate specific antigen (PSA) testing of men aged 50 - 69 years reduces the overall mortality from prostate cancer.
The objective of the study is to evaluate the effectiveness of population screening for prostate cancer by establishing a cluster randomised trial allocating general practices to either intensive case-finding (the ProtecT trial) or unscreened standard practice in order to: provide an unbiased estimate of the effect of a single screening round for prostate cancer on prostate cancer-specific and all-cause mortality in the population, and to contribute to the international effort to investigate the impact of prostate cancer screening.
As of 17/03/2010 this record was updated; all changes can be found under the relevant field with the above update date. At this time, the anticipated end date was also extended; the initial anticipated end date of this trial was 01/05/2005.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Added 17/03/2010:
Multicentre Research Ethics Committee approved on the 12th February 2004 (ref: MREC/03/4/093) and again on the 24th November 2005 (ref: 05/MRE04/78).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Prostate cancer
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Participants - inclusion criteria
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All men aged 50 - 69 years from approximately 400 GP practices in 9 UK centres (Sheffield, Newcastle, Bristol, Birmingham, Cardiff, Edinburgh, Leeds, Cambridge, Leicester)
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/03/2004
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Anticipated end date
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31/12/2015
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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230,000
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Interventions
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Practices are randomised to participate in The ProtecT study (see ISRCTN20141297) or the comparison arm of the trial. In the ProtecT arm of the trial men are being invited to be tested for the presence of prostate cancer in a process of case-finding that is almost identical to population screening. In the comparison arm men are not subject to intensive case-finding for prostate cancer.
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Primary outcome measure(s)
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Prostate cancer mortality at 10 years
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Secondary outcome measure(s)
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Measured at 5 and 10 years:
1. All cause mortality
2. Disease status and staging
3. Cost-effectiveness
4. Health related quality of life
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Sources of funding
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Cancer Research UK (CRUK) (UK) (ref: C11043/A4286). As of 17/03/2010 additional funding from CRUK was added (ref: C18281/A11326).
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21047592
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21481132
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Contact name
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Prof
Richard
Martin
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Address
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School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
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City/town
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Bristol
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Zip/Postcode
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BS8 2PS
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Country
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United Kingdom
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Sponsor
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University of Bristol (UK)
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Address
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Senate House
Tyndall Avenue
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City/town
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Bristol
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Zip/Postcode
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BS8 1TH
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Country
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United Kingdom
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Sponsor website:
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http://www.bris.ac.uk/
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Date applied
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30/09/2004
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Last edited
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01/05/2012
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Date ISRCTN assigned
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29/11/2004
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