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Evaluating population-based screening for localised prostate cancer in the United Kingdom: an extension to the ProtecT treatment trial
ISRCTN ISRCTN92187251
DOI 10.1186/ISRCTN92187251
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluating population-based screening for localised prostate cancer in the United Kingdom: an extension to the ProtecT treatment trial
Scientific title Evaluating population-based screening for localised prostate cancer in the United Kingdom: a randomised controlled extension to the ProtecT treatment trial
Acronym The CAP (Comparison Arm for ProtecT) study
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval 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).
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Prostate cancer
Participants - inclusion criteria All men aged 50 - 69 years from approximately 400 GP practices in 9 UK centres (Sheffield, Newcastle, Bristol, Birmingham, Cardiff, Edinburgh, Leeds, Cambridge, Leicester)
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/03/2004
Anticipated end date 31/12/2015
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 230,000
Interventions 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.
Primary outcome measure(s) Prostate cancer mortality at 10 years
Secondary outcome measure(s) Measured at 5 and 10 years:
1. All cause mortality
2. Disease status and staging
3. Cost-effectiveness
4. Health related quality of life
Sources of funding Cancer Research UK (CRUK) (UK) (ref: C11043/A4286). As of 17/03/2010 additional funding from CRUK was added (ref: C18281/A11326).
Trial website
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21047592
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21481132
Contact name Prof  Richard  Martin
  Address School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
  City/town Bristol
  Zip/Postcode BS8 2PS
  Country United Kingdom
Sponsor University of Bristol (UK)
  Address Senate House
Tyndall Avenue
  City/town Bristol
  Zip/Postcode BS8 1TH
  Country United Kingdom
  Sponsor website: http://www.bris.ac.uk/
Date applied 30/09/2004
Last edited 01/05/2012
Date ISRCTN assigned 29/11/2004
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