| Trial | Study Population | Study Population Description | Intervention | Median/ Maximum Length of Followup (Years) | Results | Limitations | Quality Rating | Comments |
|---|---|---|---|---|---|---|---|---|
| Quebec Labrie et al 2004 (17) | Men registered on the Quebec City area electoral rolls in 1988 | 46,486 men aged 45–80 years 31,133 men invited for screening; 23.6% received screening 15,353 controls not invited; 7.3% received screening | DRE + PSA at first visit PSA alone at subsequent screens PSA cut-off point >3.0 ng/mL; if PSA previously >3.0 ng/mL, a PSA increase of 20% over previous year value or over predicted PSA (prPSA) Positive screening test led to TRUS-guided biopsy | 7.9/11 | No difference in prostate-cancer specific mortality when data are analyzed via intention-to-screen: RR, 1.01 (95% CI, 0.82–1.40) | No information to assess adequacy of randomization Unclear if outcome assessment was blinded No baseline sociodemographic comparison of the two groups Inadequate reporting of attrition Authors did not primarily use intention- to-screen analysis | Poor | Trial included in the 2008 evidence review and previously considered by the USPSTF |
| Nörrkoping Sandblom et al 2004 (18) 2011 (13) | Male residents of Nörrkoping, Sweden identified in the Swedish National Population Register in 1987 | 9,026 men aged 50–69 years 1,494 men (every 6th man) invited for screening; 70%–78% received screening, depending on year 7,532 controls received usual care; unknown how many received screening | DRE only in 1987 and 1990 DRE + PSA in 1993 and 1996 PSA cut-off point >4.0 ng/mL Positive screening test led to biopsy; confirmed prostate cancer treated according to regional standardized management program | 6.3/20 | No difference in prostate-cancer specific mortality (RR, 1.16 [95% CI, 0.78–1.73]) or overall survival (log rank test, p=0.14) between invited and non-invited groups | Inadequate randomization and allocation concealment procedures (predictable group assignment) No baseline sociodemographic comparison of the two groups Contamination rate in control group not assessed Inadequate reporting of attrition | Poor | Trial included in the 2008 evidence review and previously considered by the USPSTF; extended followup now available Trial (and sample size/power calculation) originally designed to assess acceptance and feasibility of prostate cancer screening program, not prostate cancer mortality |
| Stockholm Kjellman et al 2009 (12) | Men living in the catchment area of Stockholm South Hospital in Sweden in 1988 | 26,602/27,204* men aged 55–70 years 2,400* men invited for screening, 74% received screening 24,202/24,804* controls from source population received usual care; contamination not reported | Single screening with DRE, TRUS, and PSA Abnormal DRE or TRUS led to biopsy PSA cut-off point >7.0 ng/mL led to repeat TRUS PSA cut-off point >10.0 ng/mL led to biopsy Treatment was “the standard care at the clinic at that time” | 12.9/15.7 | No difference in prostate cancer mortality: IRR, 1.10 (95% CI, 0.83–1.46) No difference in death from other causes: IRR, 0.98 (95% CI, 0.92–1.05) | Methods of randomization and allocation concealment unclear Unclear if outcome assessment was blinded No baseline sociodemographic comparison of the two groups Contamination rates in control group not assessed Inadequate reporting of attrition Limited applicability to current U.S. practice (high PSA threshold) | Poor | Report has internal discrepancies about the total number of participants because the file containing the registration numbers of the original cohort could not be retrieved |
| PLCO Andriole et al 2009 (6) | Men enrolled at 10 study centers in the United States from 1993–2001 | 76,693 men aged 55–74 years 38,343 men assigned to screening; overall compliance with screening was 85% for PSA and 86% for DRE 38,350 men assigned to usual care; 52% had at least one PSA during trial | Annual PSA for 6 years Annual DRE for 4 years PSA cut-off point >4.0 ng/mL Positive PSA or DRE referred to patient’s primary care physician for management | 11.5/14.8 | No difference in prostate cancer- specific mortality at 7 or 10 years: rate ratios, 1.13 (95% CI, 0.75–1.70) and 1.11 (95% CI, 0.83–1.50), respectively No difference in overall mortality (excluding prostate, lung, or colorectal cancer) at 7 or 10 years: rate ratios, 0.98 (95% CI, 0.92–1.03) and 0.97 (95% CI, 0.93–1.01), respectively | High rate of contamination in control arm (up to 52% by 6 years) Approximately 44% of men in each arm had undergone one or more PSA tests prior to trial entry | Fair | |
| ERSPC Schroder et al 2009 (7) | Men in 7 European countries enrolled from 1991–2003 | 182,160 men aged 50–74 years; 162,387 men in prespecified “core” subgroup of 55–69 years 82,816 men assigned to screening; 82% had at least one PSA test during trial 99,184 men assigned to the control group; based on single site, screening in controls estimated at ~20% | Variable by center; see Appendix 2 for details Most centers performed PSA every 4 years; some also utilized DRE or TRUS PSA cut-off points ranged from 2.5 to 10.0 ng/mL; 3.0 ng/mL most often utilized, some ancillary testing with lower PSA values Positive screen led to biopsy; treatments according to local policies and guidelines | 9/14.5 | No difference in prostate cancer- specific mortality in all enrolled men: RR, 0.85 (95% CI, 0.73–1.00) Reduced prostate cancer-specific mortality in “core” subgroup: ARR, 0.071%; RR, 0.80 (95% CI, 0.65–0.98); NNS=1,410;NNT=48 | Inconsistencies in screening intervals and PSA cut-off points among study centers Method of allocation concealment not described Differences in exclusion of men by age between centers Exclusion of data from 2 study centers (Portugal and France, which would bring the number of participating countries to 9) Inadequate reporting of attrition | Fair | |
| Substudy of ERSPC: Göteborg Hugosson et al 2010 (16) | Men born between 1930 and 1944 identified from the population register of Göteborg, Sweden in December 1994 | 19,904 men aged 50–64 years 9,952 invited to screening; 76% had at least one PSA 9,952 controls not invited to screening; contamination rate estimated at 3% | PSA every 2 years for 7 rounds PSA cut-off point ranged from 2.5 to 3.0 ng/mL, depending on year Positive screen led to DRE, TRUS, and biopsy Treatment was at the discretion of the participant’s personal physician | 14/14 | Reduced prostate cancer-specific mortality: ARR, 0.40% (95% CI, 0.17–0.64); RR, 0.56 (95% CI, 0.39–0.82); NNS=293 (95% CI, 177–799); NNT=12 | 60% of participants (men born between 1930 and 1939) previously included in overall ERSPC results No baseline demographic comparison of the two groups Inadequate reporting of attrition Contamination rate in controls not formally assessed; unclear how 3% estimate was obtained | Fair | This publication represents single center results reported separately from the overarching ERSPC trial |
Report has internal discrepancies about this number, because the file containing the registration numbers of the original cohort could not be retrieved.
Abbreviations: DRE=digital rectal examination; PSA=prostate-specific antigen; TRUS=transrectal ultrasonography; RR=relative risk; CI=confidence interval ; ARR=absolute risk reduction; NNS=number needed to screen; NNT=number needed to treat; IRR=incidence rate ratio.
From: 3, Results
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