Evidence of harms from screening for prostate cancer with PSA testing*
| Harm | Study type | Study characteristics | Proportion (95% CI) | GRADE quality of evidence† |
|---|---|---|---|---|
| Overdiagnosis‡ | ERSPC modelling data;19 various sources | 40%–56% of cases diagnosed | Very low | |
| False-positive result | ERSPC;19 uncontrolled observational study | PSA > 3.0 ng/mL as threshold for biopsy referral | 19.82% (11.51%–28.13%) of men screened | Very low |
| ERSPC19 and intervention arm of PLCO;21 uncontrolled observational study | PSA > 4.0 ng/mL as threshold for biopsy referral | 11.30% (9.92%–12.67%) of men screened | Very low | |
| Harms of biopsy | Uncontrolled observational study | < 30 d after biopsy | Hematuria§ = mean 30.86% (20.18%–41.51%) of men who had a biopsy Infection§ = mean 0.94% (0.01%–1.86%) of men who had a biopsy | Very low |
| Hospital admission = mean 2.07% (1.59%–2.54%) of men who had a biopsy | Very low | |||
| Death = mean 0.17% (0.09%–0.25%) of men who had a biopsy | Very Low |
Note: CI = confidence interval, ERSPC = European Randomized Study of Screening for Prostate Cancer, PLCO = Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, PSA = prostate-specific antigen.
↵* All data can be found in Dunfield et al.13
↵† GRADE (Grading of Recommendations, Assessment, Development and Evaluation)15 rates the continuum of quality of evidence in 4 categories of high, moderate, low or very low; see evidence review for complete assessment of study quality.13
↵‡ Overdiagnosis = the detection of cancers that would not progress to cause symptoms or death.
↵§ Not requiring hospital admission.