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Cluster randomised triAl of PSA testing for Prostate cancer
ISRCTN ISRCTN92187251
DOI 10.1186/ISRCTN92187251
ClinicalTrials.gov identifier
EudraCT number
Public title Cluster randomised triAl of PSA testing for Prostate cancer
Scientific title Cluster randomised triAl of PSA testing for Prostate cancer
Acronym CAP
Serial number at source N/A
Study hypothesis Current hypothesis as of 06/08/2014:
The hypothesis under investigation is that population screening in the form of prostate specific antigen (PSA) testing of men aged 50 - 69 years reduces 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 population-based PSA testing (the ProtecT trial, ISRCTN20141297) 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.

Previous 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.

On 17/03/2010 the trial record was updated; all changes can be found under the relevant field with the above update date. The anticipated end date was also changed from 01/05/2005 to 31/12/2015.

On 06/08/2014 the following changes were made to the trial record:
1. The public title was changed from 'Evaluating population-based screening for localised prostate cancer in the United Kingdom: an extension to the ProtecT treatment trial' to 'Cluster randomised triAl of PSA testing for Prostate cancer'
2. The scientific title was changed from 'Evaluating population-based screening for localised prostate cancer in the United Kingdom: a randomised controlled extension to the ProtecT treatment trial' to 'Cluster randomised triAl of PSA testing for Prostate cancer '
3. The anticipated end date was changed from 31/12/2015 to 01/03/2016
4. The target number of participants was changed from 230,000 to 416,000
Lay summary Background and study aims
Screening for prostate cancer continues to cause controversy because of concerns about over-diagnosis and unnecessary treatment. The aim of this study is to help policy makers decide whether PSA testing for prostate cancer should be introduced by evaluating the effectiveness of PSA testing in reducing prostate cancer mortality (i.e. the number of deaths), and its cost-effectiveness (i.e. comparing the health-related costs in combination with the effectiveness of PSA testing, in order to assist policy makers in their decisions about how to achieve the best use of resources).

Who can participate?
Men aged 50 - 69 years from about 573 GP practices in eight UK centres (Sheffield, Newcastle, Bristol, Birmingham, Cardiff, Leeds, Cambridge and Leicester).

What does the study involve?
Participants will be randomly allocated to one of two groups. One group is invited to have a PSA test (‘population-based PSA testing’) and the other group continues to receive standard NHS care in the UK, based on the NHS prostate cancer risk management programme. The study involves medical records being looked at by trained researchers working with local NHS Trusts. Trained researchers will put information about any tests or treatment received for prostate problems onto a computer, making sure no personal details (name, address etc.) will be recorded. Data will be identified only by a study number.

What are the possible benefits and risks of participating?
The study will have no impact on an individual’s medical care. There are no direct benefits, although participation will contribute towards a better understanding of how prostate problems are currently diagnosed and managed by UK doctors.

Where is the study run from?
University of Bristol (UK).

When is the study starting and how long is it expected to run for?
The study started in March 2004 and will run until March 2016.

Who is funding the study?
Cancer Research UK (CRUK) (UK).

Who is the main contact?
Prof Richard Martin
Ethics approval Randomisation of practices into intervention (ISRCTN20141297) and control arms approved on 21/06/2001 (ref: MREC/01/4/025), also permitted follow-up of participants in the intervention arm. Multicentre Research Ethics Committee approval on 12/02/2004 (ref: MREC/03/4/093) gave permission for follow-up in the control arm, and review of medical records on 24/11/2005 (ref: 05/MRE04/78).
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Prostate cancer
Participants - inclusion criteria Current inclusion criteria as of 06/08/2014:
All men aged 50 - 69 years from 573 GP practices in eight UK centres (Sheffield, Newcastle, Bristol, Birmingham, Cardiff, Leeds, Cambridge, Leicester). An additional centre, Edinburgh, where routine data on cause of death did not undergo validation, will be included in a secondary analysis.

Previous inclusion criteria:
All men aged 50 - 69 years from approximately 400 GP practices in nine UK centres (Sheffield, Newcastle, Bristol, Birmingham, Cardiff, Edinburgh, Leeds, Cambridge, Leicester)
Participants - exclusion criteria Current exclusion criteria as of 06/08/2014:
Inclusion criteria not met. Men identified as already having a prostate cancer diagnosis.

Previous exclusion criteria:
Does not meet inclusion criteria
Anticipated start date 01/03/2004
Anticipated end date 01/03/2016
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 416,000
Interventions Current interventions as of 06/08/2014:
General practices are randomised to participate in The ProtecT study (see ISRCTN20141297) or the control arm of the trial. In the ProtecT arm of the trial men are being invited to be tested for the presence of prostate cancer through population-based PSA testing. In the control arm men receive standard NHS care (NHS prostate cancer risk management programme).

Previous 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

Added 06/08/2014:
See statistical analysis plan for further details: http://hdl.handle.net/1983/6d41509f-ab93-4f96-9869-c320acbc4ae1
Secondary outcome measure(s) Current secondary outcome measures as of 06/08/2014:
Measured at 5 and 10, 15 and 20 years:
1. All-cause mortality
2. Disease status and staging
3. Cost-effectiveness
4. Health-related quality of life

Previous secondary outcome measures:
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) (refs: C11043/A4286, C18281/A11326, C18281/A8145 and C18281/A15064)
Trial website
Publications 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18156520
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19299260
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21047592
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21481132
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23734773
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24867688
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 26/08/2014
Date ISRCTN assigned 29/11/2004
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