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Cluster randomised triAl of PSA testing for Prostate cancer

Cluster randomised triAl of PSA testing for Prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN92187251
Enrollment
416000
Registered
2004-11-29
Start date
2004-03-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Malignant neoplasm of prostate

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 a

Sponsors

University of Bristol (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026