Table 2:

Evidence of harms from screening for prostate cancer with PSA testing*

HarmStudy typeStudy characteristicsProportion (95% CI)GRADE quality of evidence
OverdiagnosisERSPC modelling data;19 various sources40%–56% of cases diagnosedVery low
False-positive resultERSPC;19 uncontrolled observational studyPSA > 3.0 ng/mL as threshold for biopsy referral19.82% (11.51%–28.13%) of men screenedVery low
ERSPC19 and intervention arm of PLCO;21 uncontrolled observational studyPSA > 4.0 ng/mL as threshold for biopsy referral11.30% (9.92%–12.67%) of men screenedVery low
Harms of biopsyUncontrolled observational study< 30 d after biopsyHematuria§ = 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 biopsyVery low
Death = mean 0.17% (0.09%–0.25%) of men who had a biopsyVery 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.