Prostate cancer is an important and growing public health problem. PSA test
ing is able to lead to the identification of large numbers of cases of pros
tate cancer while still asymptomatic. This provides the potential for impor
tant reductions in prostate cancer mortality through the introduction of sc
reening programs. The most reliable evidence that this potential can be rea
lised can only come from randomised controlled trials (RCTs). Alternative s
ources of evidence are compared with that from RCTs; the costs of a wrong d
ecision would be high and it is argued that the case for RCTs is clear. (C)
2000 Wiley-Liss, Inc.