established in 1812
may 27 , 2004
Prevalence of Prostate Cancer among Men with a Prostate-Specific Antigen Level ≤4.0 ng per Milliliter
Ian M. Thompson, M.D., Donna K. Pauler, Ph.D., Phyllis J. Goodman, M.S., Catherine M. Tangen, Dr.P.H., M. Scott Lucia, M.D., Howard L. Parnes, M.D., Lori M. Minasian, M.D., Leslie G. Ford, M.D.,Scott M. Lippman, M.D., E. David Crawford, M.D., John J. Crowley, Ph.D., and Charles A. Coltman, Jr., M.D.
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.
Of 18,882men 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 of1.1 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
From the Division of Urology, Department of Surgery, University of Texas Health Science Center at San Antonio, San Antonio (I.M.T.); the Fred Hutchinson Cancer Research Center, Seattle (D.K.P., P.J.G., C.M.T.); the University of Colorado Health Science Center, Denver (M.S.L., E.D.C.); the Division of Cancer Prevention, National Cancer Institute, Bethesda, Md. (H.L.P., L.M.M.,L.G.F.); the Department of Clinical Cancer Prevention, M.D. Anderson Cancer Center, Houston (S.M.L.); Cancer Research and Biostatistics, Seattle (J.J.C.); and the Southwest Oncology Group, San Antonio, Tex. (C.A.C.). Address reprint requests to the Southwest Oncology Group (SWOG-9217), Operations Office, 14980 Omicron Dr., San Antonio, TX 78245-3217. N Engl J Med 2004;350:2239-46.
Copyright © 2004Massachusetts Medical Society.
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.
n engl j med 350;22
may 27, 2004
Downloaded from www.nejm.org by JULIA ESTHER CARRANZA MD on August 30, 2009 . Copyright © 2004 Massachusetts MedicalSociety. All rights reserved.
new england journal
hen first described in 1979, prostate-specific antigen (PSA) was considered a useful marker for assessing treatment responses and follow-up among patients with prostate cancer.1 After the publication of reports on several series in which the need for a biopsy of the prostate was based on the results of PSA tests,the potential of the PSA level as a screening tool was recognized.2,3 Further experience led to the consensus that a PSA level of more than 4.0 ng per milliliter had predictive value for the diagnosis of prostate cancer.4 Disease detection subsequently increased dramatically.5 More recent data suggest that a PSA level of more than 2.5 ng per milliliter has a predictive value similar to that of a...