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.
Background The optimal upper limit of the normal range for prostate-specificantigen (PSA) is unknown. We investigated the prevalence ofprostate cancer among men in the Prostate Cancer PreventionTrial who had a PSA level of 4.0 ng per milliliter or less.
Methods Of 18,882 men enrolled in the prevention trial, 9459were randomly assigned to receive placebo and had an annualmeasurement of PSA and a digital rectal examination. Among these9459 men, 2950 men never had a PSA level of more than 4.0 ngper milliliter or an abnormal digital rectal examination, hada final PSA determination, and underwent a prostate biopsy afterbeing in the study for seven years.
ResultsAmong the 2950 men (age range, 62 to 91 years), prostatecancer was diagnosed in 449 (15.2 percent); 67 of these 449cancers (14.9 percent) had a Gleason score of 7 or higher. Theprevalence of prostate cancer was 6.6 percent among men witha PSA level of up to 0.5 ng per milliliter, 10.1 percent amongthose with values of 0.6 to 1.0 ng per milliliter, 17.0 percentamong those with values of 1.1 to 2.0 ng per milliliter, 23.9percent 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 permilliliter. The prevalence of high-grade cancers increased from12.5 percent of cancers associated with a PSA level of 0.5 ngper milliliter or less to 25.0 percent of cancers associatedwith a PSA level of 3.1 to 4.0 ng per milliliter.
Conclusions Biopsy-detected prostate cancer, including high-gradecancers, is not rare among men with PSA levels of 4.0 ng permilliliter or less levels generally thought to be inthe normal range.
Source Information
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.
Prostate Cancer with Low PSA Levels
Beatty P. A., Glaser A. I., Rocco B., Matei D. V., de Cobelli O., Datta M. W., Berman J. J., Dhir R.
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N Engl J Med 2004;
351:1802-1803, Oct 21, 2004.
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