Cluster randomised triAl of PSA testing for Prostate cancer
| ISRCTN | ISRCTN92187251 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92187251 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/09/2004
- Registration date
- 29/11/2004
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English 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 individuals 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?
March 2004 to March 2016
Who is funding the study?
Cancer Research UK (CRUK) (UK)
Who is the main contact?
Prof Richard Martin
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-a-single-blood-test-for-prostate-cancer-cap
Contact information
Scientific
School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Cluster randomised triAl of PSA testing for Prostate cancer |
| Study acronym | CAP |
| 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. |
| Ethics approval(s) | 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). |
| Condition | Prostate cancer |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 04/02/2021: Prostate cancer mortality at 15 years See statistical analysis plan for further details: http://hdl.handle.net/1983/97a58ee2-e559-49e3-9029-954bd5dd5bd9 DOI: 10.17605/OSF.IO/7Y3G6 _____ Previous primary outcome measure: 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 measures | Current secondary outcome measures as of 04/02/2021: Measured at 5 and 10, 15 and 20 years: 1. All-cause mortality 2. Disease status and staging 3. Cost-effectiveness: The projected lifetime effectiveness and cost-effectiveness of a range of UK-focused screening options, incorporating parameter estimates computed from CAP and ProtecT data to create a UK-specific decision analytic model 4. Health-related quality of life 5. Age-specific lead-time and over-diagnosis rates (utilising observed trial data) _____ Previous 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 |
| Overall study start date | 01/03/2004 |
| Overall study end date | 01/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 416,000 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 01/03/2004 |
| Recruitment end date | 01/03/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BS8 2PS
United Kingdom
Sponsor information
University/education
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Website | http://www.bris.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Statistical analysis plan at https://osf.io/7y3g6 (added 04/02/2021) |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2008 | Yes | No | |
| Results article | results | 01/04/2009 | Yes | No | |
| Results article | results | 01/11/2010 | Yes | No | |
| Results article | results | 01/11/2011 | Yes | No | |
| Results article | results | 04/06/2013 | Yes | No | |
| Results article | results | 10/06/2014 | Yes | No | |
| Results article | results | 23/01/2015 | Yes | No | |
| Results article | results | 29/04/2016 | Yes | No | |
| Results article | results | 13/10/2016 | Yes | No | |
| Results article | results | 06/03/2018 | Yes | No | |
| Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link added.
04/02/2021: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
3. The trial website was added.
4. Link to statistical analysis plan added to publication and dissemination plan.
08/03/2018: Publication reference added.
17/10/2016: Publication reference added.
05/05/2016: Publication reference added.
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 overall trial 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.
17/03/2010: The overall trial end date was also changed from 01/05/2005 to 31/12/2015.
