Randomised prostate cancer screening trial: 20 year follow-upBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d1539 (Published 31 March 2011) Cite this as: BMJ 2011;342:d1539
- Gabriel Sandblom, associate professor1,
- Eberhard Varenhorst, professor2,
- Johan Rosell, statistician3,
- Owe Löfman, professor4,
- Per Carlsson, professor5
- 1CLINTEC, Karolinska Institute, 141 86 Stockholm, Sweden
- 2Department of Urology, Linköping University Hospital, Linköping
- 3Oncology Centre, Linköping University Hospital, Linköping
- 4Department of Mathematical Science and Technology, Norwegian University of Life Sciences, 1432 Aas, Norway
- 5Center for Health Technology Assessment, Linköping University, Linköping
- Correspondence to: G Sandblom
- Accepted 24 December 2010
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.
Contributors: GS drafted the manuscript, with contributions from all other coauthors. EV organised the screening programme with OL and PC. EV also conceived the study design. JR did all the analyses. GS is guarantor.
Funding: This study was funded by the Research Council of the South-East Region of Sweden (No F97-318), the Swedish Cancer Foundation, and the County Council of Östergötland.
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.
Ethical approval: This study was approved by the institutional review board of Linköping, Sweden, 1992. Participants gave informed consent for data sharing.
Data sharing: Technical appendix, statistical code, dataset and the full study protocol are available from.
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