Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter.
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.
Thompson
Ian M
IM
Division of Urology, Department of Surgery, University of Texas Health Science Center at San Antonio, San Antonio, Tex, USA.
Pauler
Donna K
DK
Goodman
Phyllis J
PJ
Tangen
Catherine M
CM
Lucia
M Scott
MS
Parnes
Howard L
HL
Minasian
Lori M
LM
Ford
Leslie G
LG
Lippman
Scott M
SM
Crawford
E David
ED
Crowley
John J
JJ
Coltman
Charles A
CA
D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001706:Biopsy; D018120:Finasteride / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011467:Prostate / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000453:epidemiology* / Q000473:pathology / Q000517:prevention & control; D012306:Risk
D018931:Antineoplastic Agents, Hormonal; D018120:Finasteride; D017430:Prostate-Specific Antigen