title: The use of age-specific reference ranges for serum prostate specific antigen in men 60 years old or older.
abstract: Several investigations have determined that the serum prostate specific antigen (PSA) concentration is dependent upon patient age and, as a result, reference ranges wider than 0.0 to 4.0 ng./ml. have been suggested for men 60 years old or older. To determine the clinical usefulness of the age-specific reference ranges--0.0 to 4.5 ng./ml. for men 60 to 69 years old and 0.0 to 6.5 ng./ml. for men 70 years old or older--the medical records of 2,988 men 60 years old or older who presented to a single urological practice were examined. All patients were evaluated with a serum PSA determination, digital rectal examination and transrectal ultrasound. A total of 1,686 prostate biopsies was performed (biopsy rate 56%) and 608 cancers were diagnosed (cancer detection rate 20%). By using the age-specific reference ranges as compared to the 0.0 to 4.0 ng./ml. reference range, the sensitivity of PSA for detecting early prostate cancer decreased by 9%, while the specificity and positive predictive value increased by 11% and 5%, respectively. If the age-specific reference ranges had been used 92 prostate biopsies (5.5%) performed could have been avoided, while 19 men in the study population (0.6%) would not have had prostate cancer diagnosed. Of the nondetected cancers 13 (67%) occurred in men 70 years old or older and 18 (95%) were small tumors of favorable pathological status unlikely to be of clinical consequence in these older men. These preliminary findings support the clinical usefulness of the wider age-specific reference ranges in men 60 years old or older. A prospective randomized clinical trial is currently underway to confirm the appropriateness of age-specific reference ranges compared to the reference range of 0.0 to 4.0 ng./ml.
authors.affiliation: Department of Urology, Mayo Clinic, Rochester, Minnesota.
authors.forename: J E
authors.initials: JE
authors.lastname: Oesterling
authors.forename: S J
authors.initials: SJ
authors.lastname: Jacobsen
authors.forename: W H
authors.initials: WH
authors.lastname: Cooner
mesh_terms: D000367:Age Factors; D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000175:diagnosis*; D012016:Reference Values; D012680:Sensitivity and Specificity
chemical_list: D017430:Prostate-Specific Antigen