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The Göteborg randomised population based prostate cancer screening trial

The Göteborg prostate cancer screening trial: a population-based randomised controlled trial of a screening group invited for biennial prostate specific antigen (PSA) testing versus a control group not invited

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54449243
Enrollment
20000
Registered
2010-06-29
Start date
1995-01-01
Completion date
Unknown
Last updated
2015-01-13

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 the prostate

Interventions

Men allocated to the screening arm are invited every second year for PSA testing, until they reach the upper age limit (70 years). Only men with PSA at or above the threshold (greater than or equal to
the incidence of prostate cancer, stage, grade and primary treatment as well as cause of death will be registered in the control group. Last invitaion to the study will be in 2014 but follow-up will

Sponsors

Sahlgrenska University Hospital (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Men born during 1930 through 1944 living in the city of Göteborg, Sweden

Exclusion criteria

Exclusion criteria: 1. Men with a prior diagnosis of prostate cancer 2. Men who had died or emigrated but had not been removed from the Population Register at time of randomisation

Design outcomes

Primary

MeasureTime frame
Prostate cancer specific mortality (absolute and relative risk reduction in cumulative prostate cancer mortality) analysed according to the intention-to-screen principle (comparing the screening group with the control group). Analysed at study completion (after 15 years).

Secondary

MeasureTime frame
1. Cumulative prostate cancer incidence and the proportion of screening attendees 2. Comparisons of stage and age distribution 3. Lead and length time bias 4. Quality of life between screened men and controls Analysed at study completion.

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026