Göteborg-1
Göteborg randomised population-based prostate-cancer screening trial
N = 20,000
- Population
- Men born 1930 to 1944 randomly sampled from the population register (10,000 per group; 48 per group excluded for death or emigration before randomisation or prevalent prostate cancer).
- Design
- Population-based randomised trial started in December 1994. Men born 1930 to 1944, randomly sampled from the population register, were randomised by computer 1:1 to PSA testing every 2 years (invited up to an upper age limit, median 69 years) or to a control group not invited; only men with raised PSA were offered further tests such as digital rectal examination and prostate biopsy. Analysis followed the intention-to-screen principle. The trial was designed and started independently of ERSPC, became associated with it in 1996, and results for men born 1930-1939 were included in the earlier ERSPC publication (full text).
- Primary endpoint
- Prostate cancer mortality
- Arms
- Invited for PSA testing (experimental, n = 10,000): Invitation to PSA testing every 2 years up to the upper age limit; further tests only if PSA raised
- Not invited (control, n = 10,000): Not invited for screening
- People
- Hugosson J
Δ 168-month Prostate cancer mortality−0.4 pointsCumulative incidence of prostate cancerHR 1.64 (95% CI 1.5–1.8)Δ Cumulative incidence of prostate cancer+4.5 points
Show the numbers
| Endpoint | Analysis | Invited for PSA testing | Not invited | Effect |
|---|---|---|---|---|
| Prostate cancer mortalityMen analysed after exclusions, intention to screen (9952 per group)Absolute cumulative risk of death from prostate cancer at 14 years. | primarymedian follow-up 14 yearsHugosson 2010 | 0.5% at 14 y | 0.9% at 14 y | P=0.002Rate ratio for death from prostate cancer 0.56 (95% CI 0.39-0.82; p=0.002) for screening versus control (a rate ratio, not a hazard ratio); absolute cumulative risk reduction 0.40% (95% CI 0.17-0.64). Rate ratio for attendees compared with the control group 0.44 (95% CI 0.28-0.68). 293 men (95% CI 177-799) needed to be invited and 12 diagnosed to prevent one prostate cancer death. First planned report. |
| Cumulative incidence of prostate cancerMen analysed after exclusions, intention to screen (9952 per group)Cumulative prostate-cancer incidence during a median follow-up of 14 years. | primarymedian follow-up 14 yearsHugosson 2010 | 12.7% | 8.2% | HR 1.64 (95% CI 1.5–1.8)P<0.00011138 men in the screening group and 718 in the control group were diagnosed with prostate cancer; 7578 (76%) of 9952 men randomised to screening attended at least once. |
| Endpoint | Analysis | Invited for PSA testing | Not invited | Effect |
|---|---|---|---|---|
| Prostate cancer mortalityMen analysed after exclusions, intention to screen (9952 per group)Absolute cumulative risk of death from prostate cancer at 14 years. | primarymedian follow-up 14 yearsHugosson 2010 | 0.5% at 14 y | 0.9% at 14 y | P=0.002Rate ratio for death from prostate cancer 0.56 (95% CI 0.39-0.82; p=0.002) for screening versus control (a rate ratio, not a hazard ratio); absolute cumulative risk reduction 0.40% (95% CI 0.17-0.64). Rate ratio for attendees compared with the control group 0.44 (95% CI 0.28-0.68). 293 men (95% CI 177-799) needed to be invited and 12 diagnosed to prevent one prostate cancer death. First planned report. |
| Cumulative incidence of prostate cancerMen analysed after exclusions, intention to screen (9952 per group)Cumulative prostate-cancer incidence during a median follow-up of 14 years. | primarymedian follow-up 14 yearsHugosson 2010 | 12.7% | 8.2% | HR 1.64 (95% CI 1.5–1.8)P<0.00011138 men in the screening group and 718 in the control group were diagnosed with prostate cancer; 7578 (76%) of 9952 men randomised to screening attended at least once. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| Cumulative incidence of prostate cancer | 1.64 | 1.5–1.8 |