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The American screening trial that found no benefit, and the reason is the trial itself: half the men in the group that was supposed to go unscreened were getting PSA tests from their own doctors.
PLCO randomised 76,693 men at ten United States centres between 1993 and 2001 to annual prostate-specific antigen testing for six years with digital rectal examination for four years, or to usual care. Compliance in the screened group was 85 percent for PSA and 86 percent for rectal examination.
The finding that matters for reading the result is in the control group: PSA testing there rose from 40 percent in the first year to 52 percent in the sixth, with rectal examination in 41 to 46 percent. The trial therefore compared organised annual screening with widespread opportunistic screening, not with no screening at all.
After seven years the incidence of prostate cancer was 116 per 10,000 person-years in the screened group against 95 in the control group, and the death rate was 2.0 against 1.7 per 10,000 person-years, a rate ratio of 1.13 that was not significant. The ten-year data, 67 percent complete at the time of the report, were consistent.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
50 deaths. · 44 deaths.
Source2,820 cancers; rate ratio 1.22 (1.16 to 1.29). · 2,322 cancers.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Death from prostate cancer at 7 yearsprimary | Annual PSA and digital rectal examination | 38,343 | 2 per 10,000 person-years | 1.13 (0.75 to 1.7) | - | link |
| Usual care | 38,350 | 1.7 per 10,000 person-years | ||||
| Prostate cancer incidence at 7 years | Annual PSA and digital rectal examination | 38,343 | 116 per 10,000 person-years | - | - | link |
| Usual care | 38,350 | 95 per 10,000 person-years |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares ERSPC (European Randomized Study of Screening for Prostate Cancer), Overdiagnosis, PSA (prostate-specific antigen), Prostate cancer.
Shares Overdiagnosis, PSA (prostate-specific antigen), Prostate cancer.
Shares Overdiagnosis, PSA (prostate-specific antigen), Prostate cancer.
Shares Overdiagnosis, PSA (prostate-specific antigen), Prostate cancer.
Shares Overdiagnosis, PSA (prostate-specific antigen), Prostate cancer.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/