SERIAL PROSTATE-SPECIFIC ANTIGEN MEASUREMENTS IN MEN WITH CLINICALLY BENIGN PROSTATIC HYPERPLASIA DURING A 12-MONTH PLACEBO-CONTROLLED STUDY WITH TERAZOSIN

Objectives, To prospectively analyze whether the treatment of men with clinically benign prostatic hyperplasia (BPH) with alpha blocking age nts affects the serum prostate-specific antigen (PSA) levels, and to d etermine the magnitude of such effect. Methods. Serial PSA measurement s were performed using the Abbott IMx assay over 1 year in 134 men ove r the age of 55 years participating in the Hytrin Community Assessment Trial (HYCAT). HYCAT is a 1-year, randomized, placebo-controlled, dou ble-blinded study of the alpha(1)-adrenergic antagonist terazosin. All men had lower urinary tract symptoms and a clinical diagnosis of BPH with an American Urological Association (AUA) symptom index of 13 poin ts or more, an AUA bother score of 8 points or more, and a peak urinar y flow rate of less than 15 mL/s. PSA was measured at baseline and at 8, 26, 39, and 52 (end of study) weeks. Results. Baseline serum PSA le vels weakly correlated with patients' age at study entry, and modestly with residual urine (positive correlation) and peak flow rate (negati ve correlation), although none of the levels were statistically signif icant. Changes of serum PSA during the course of the study did not cor relate with either one of the symptom severity or bother assessment to ols, residual urine, or peak flow rate. Mean PSA increased from a base line of 2.5 +/- 0.22 ng/mL (mean +/- SE) by 0.5 +/- 0.11 ng/mL in the placebo-, and from 2.7 +/- 0.23 ng/mL by 0.3 +/- 0.11 ng/mL in the ter azosin-treated patients (P = 0.36 by ANOVA). There were no differences in the changes in serum PSA when patients were stratified by decade o f life according to the age-specific PSA reference ranges, or by the f inal dose of terazosin (2, 5, or 10 mg daily). Conclusions. The treatm ent of men with lower urinary tract symptoms and clinical BPH with the alpha(1)-adrenergic antagonist terazosin does not affect serum PSA co ncentration, and thus does not confound longitudinal monitoring of ser um PSA levels in patients at risk for prostate carcinoma. (C) 1997, El sevier Science Inc. All rights reserved.