Prevalence of Prostate Cancer among Men with a Prostate-Specific
Antigen Level 4.0 ng per Milliliter
Ian M. Thompson, NEJM 2004;350:2239
Background The optimal upper limit of
the normal range for prostate-specific antigen (PSA) is unknown. We investigated the
prevalence of prostate cancer among men in the Prostate Cancer Prevention Trial who had a
PSA level of 4.0 ng per milliliter or less.
Methods Of 18,882 men enrolled in the prevention trial, 9459 were randomly assigned to
receive placebo and had an annual measurement of PSA and a digital rectal examination.
Among these 9459 men, 2950 men never had a PSA level of more than 4.0 ng per milliliter
or an abnormal digital rectal examination, had a final PSA determination, and underwent a
prostate biopsy after being in the study for seven years.
Results Among the 2950 men (age range, 62 to 91 years), prostate cancer was diagnosed
in 449 (15.2 percent); 67 of these 449 cancers (14.9 percent) had a Gleason score of 7 or
higher. The prevalence of prostate cancer was 6.6 percent among men with a PSA level
of up to 0.5 ng per milliliter, 10.1 percent among those with values of 0.6 to 1.0 ng per
milliliter, 17.0 percent among those with values of 1.1 to 2.0 ng per milliliter, 23.9
percent among those with values of 2.1 to 3.0 ng per milliliter, and 26.9 percent among
those with values of 3.1 to 4.0 ng per milliliter. The prevalence of high-grade cancers
increased from 12.5 percent of cancers associated with a PSA level of 0.5 ng per
milliliter or less to 25.0 percent of cancers associated with a PSA level of 3.1 to 4.0 ng
per milliliter.
Conclusions Biopsy-detected prostate cancer, including high-grade cancers, is not rare
among men with PSA levels of 4.0 ng per milliliter or less levels generally thought
to be in the normal range. |