Objective: To critically evaluate the evidence for recommending the sc
reening of asymptomatic men for prostate cancer with a blood test to d
etect a prostate-specific antigen (PSA). Data Sources: Relevant articl
es on screening for prostate cancer were identified from MEDLINE searc
hes, from the authors' files, and from the bibliographies of identifie
d articles. Study Selection: In the absence of controlled prospective
trials, the studies are primarily retrospective and contain informatio
n about the sensitivity, specificity, and predictive values of tests u
sed to screen for prostate cancer; the natural history of untreated pr
ostate cancer; the morbidity, mortality, and costs of definitive treat
ment; and reviews of screening study biases. Data Extraction: Potentia
l treatment-related mortality and costs that could be incurred by scre
ening were estimated using defined assumptions. Results: Although scre
ening for prostate cancer has the potential to save lives, because of
possible over-diagnosis, screening and subsequent therapy could actual
ly have a net unfavorable effect on mortality or quality of life or bo
th. Given the performance characteristics of the test, widespread scre
ening efforts would probably cost billions of dollars. Conclusions: Th
e net benefit from widespread screening is unclear. A randomized prosp
ective study of the effect of screening on prostate cancer mortality h
as therefore been initiated by the National Cancer Institute.