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Randomized Controlled Trial
. 2011 Mar 31:342:d1539.
doi: 10.1136/bmj.d1539.

Randomised prostate cancer screening trial: 20 year follow-up

Gabriel Sandblom  1 , Eberhard Varenhorst, Johan Rosell, Owe Löfman, Per Carlsson
Affiliations
Randomized Controlled Trial

Randomised prostate cancer screening trial: 20 year follow-up

Gabriel Sandblom et al. BMJ. .

Abstract

Objective: To assess whether screening for prostate cancer reduces prostate cancer specific mortality.

Design: Population based randomised controlled trial.

Setting: Department of Urology, Norrköping, and the South-East Region Prostate Cancer Register.

Participants: All men aged 50-69 in the city of Norrköping, Sweden, identified in 1987 in the National Population Register (n = 9026).

Intervention: From the study population, 1494 men were randomly allocated to be screened by including every sixth man from a list of dates of birth. These men were invited to be screened every third year from 1987 to 1996. On the first two occasions screening was done by digital rectal examination only. From 1993, this was combined with prostate specific antigen testing, with 4 µg/L as cut off. On the fourth occasion (1996), only men aged 69 or under at the time of the investigation were invited.

Main outcome measures: Data on tumour stage, grade, and treatment from the South East Region Prostate Cancer Register. Prostate cancer specific mortality up to 31 December 2008.

Results: In the four screenings from 1987 to 1996 attendance was 1161/1492 (78%), 957/1363 (70%), 895/1210 (74%), and 446/606 (74%), respectively. There were 85 cases (5.7%) of prostate cancer diagnosed in the screened group and 292 (3.9%) in the control group. The risk ratio for death from prostate cancer in the screening group was 1.16 (95% confidence interval 0.78 to 1.73). In a Cox proportional hazard analysis comparing prostate cancer specific survival in the control group with that in the screened group, the hazard ratio for death from prostate cancer was 1.23 (0.94 to 1.62; P = 0.13). After adjustment for age at start of the study, the hazard ratio was 1.58 (1.06 to 2.36; P = 0.024).

Conclusions: After 20 years of follow-up the rate of death from prostate cancer did not differ significantly between men in the screening group and those in the control group. Trial registration Current Controlled Trials, ISRCTN06342431.

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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Fig 1 Flow chart of study group enrolment. DRE=digital rectal examination, PSA=prostate specific antigen
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Fig 2 Kaplan-Meier curves of overall survival for men diagnosed with prostate cancer in control group (n=292) and screened group (n=85). Log rank test P=0.14
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Fig 3 Kaplan-Meier curves of prostate cancer specific survival for men diagnosed with prostate cancer in control group (n=292) and screened group (n=85). Log rank test P=0.065
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Fig 4 Cumulative rates of prostate cancer specific mortality
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