Table 3:
Key Characteristics of RCTs of PSA Screening Programs for Prostate Cancer
| Study, Country | Randomization Process | Entry Age Range, Mean, Years | Screening Intervals and Rounds | Sample Size Screen/Control, n | Screen Tests and Biopsy Threshold |
|---|---|---|---|---|---|
| North America | |||||
| PLCO, United States | Volunteers; after consent | 55–74 | Annual | 38,343 / 38,350 | Total PSA (6 years) and DRE (4 years) Total PSA > 4 ng/ml or abnormal DRE |
| Canada, Quebec | Population; before consent | 45–80 | Annual | 30,956 / 15,237 | Total PSA, DRE, TRUS Visit 1: PSA + DRE and TRUS (if PSA > 3.0 ng/ml or abnormal DRE; first 1,002 had all 3 tests) Visits > 1: TRUS if PSA > 3.0 ng/ml |
| Europe | |||||
| ERSPC, Belgium | Volunteers; after consent | 55–74 | 7-year interval (between first and second round) and then 4-year interval for 3 screening rounds | 8,750 / 8,750 | Total PSA |
| ERSPC, Netherlands, Rotterdam | Population; after consent | 55–69 (core) and 70–74 | 4-year interval | 21,210 / 19,970 | Total PSA, DRE and TRUS 3 different screens First screen PSA ≥ 4.0 ng/ml or abnormal DRE or abnormal TRUS; Subsequent screens PSA ≥ 3.0 ng/ml |
| ERSPC, Finland | Population; before consent | Age cohorts 55, 59, 63, or 67 years | 4-year interval for 3 screening rounds | 31,866 / 48,278 | Total PSA ≥ 4 ng/ml or total PSA 3.0–3.9 ng/ml and abnormal DRE (1996–1998) and since 1999 free/total PSA of < 16% |
| ERSPC, Italy | Population; before consent | 55–70 | 4-year interval | 7,286 / 7,271 | Total PSA 2.5 to 3.9 ng/ml followed by DRE and TRUS |
| ERSPC, Spain | Volunteers; after consent | 50–70 | 4-year interval for screening rounds | 2,416 / 1,862 | Total PSA Total PSA > 4 ng/ml initially, total PSA > 2.99 ng/ml, then total PSA 1–2.99 mg/ml and free/total PSA ≤ 20% |
| ERSPC, Sweden, Goteborg | Population; before consent | 50–65 | 2-year intervals for 7 screening rounds | 9,972 / 9,973 | Total PSA, DRE, TRUS Initially Total PSA > 3.0 ng/ml (1995–1998) lowered to 2.5 ng/ml 92005) |
| ERSPC, Switzerland | Population; after consent | 55–70 | 4-year interval | 5,150 / 5,150 | Total PSA Free-to-Total PSA Total PSA > 3.0 ng/ml or Total PSA = 1–3 ng/ml and free-to-total PSA < 20% |
| ERSPC, France | Population; before consent | 55–69 | 2-year interval | 42,590 / 42,191 | Total PSA ≥ 3 ng/ml |
| Sweden, Norrkoping | Population; before consent | 50–69 | 3-year interval | 1,494 / 7,532 | First screen, DRE by urologist and GP (second and subsequent screens by GP only); third and fourth screen DRE and PSA (1993) Abnormal DRE and PSA > 4ng/ml |
| Sweden, Stockholm | Population; before consent | 55–70 | Screened once | 2,400 / 24,202 | Total PSA, DRE, and TRUS PSA > 7 ng/ml, repeat TRUS Total PSA > 10 ng/ml |
| Sweden, Goteborg | Population; before consent | 50–65 | 2-year interval | 10,000 / 10,000 | Total PSA Total PSA ≥ 3.0 ng/ml |
Abbreviations: CODC, Cause of Death Committee; DRE, digital rectal exam; ERSPC, European Randomized Study of Screening for Prostate Cancer; GP, general practitioner; PLCO, Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial; PSA; prostate-specific antigen; TRUS, transrectal ultrasound.