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Serum prostate-specific antigen and prostate volume predict long-term changes in symptoms and flow rate: results of a four-year, randomized trial comparing finasteride versus placebo

Objectives. To determine whether baseline prostate-specific antigen (PSA), in addition to prostate volume, is associated with long-term changes in symptoms and urinary flow rate. Methods. Three thousand forty men with benign prostatic hyperplasia enrolled in the PLESS trial were randomly assigned to...

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Bibliographic Details
Published in:Urology (Ridgewood, N.J.) N.J.), 1999-10, Vol.54 (4), p.662-669
Main Authors: Roehrborn, Claus G., Boyle, Peter, Bergner, Donald, Gray, Todd, Gittelman, Marc, Shown, Thomas, Melman, Arnold, Bracken, R.Bruce, deVere White, Ralph, Taylor, Alice, Wang, Daniel, Waldstreicher, Joanne
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Language:English
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Summary:Objectives. To determine whether baseline prostate-specific antigen (PSA), in addition to prostate volume, is associated with long-term changes in symptoms and urinary flow rate. Methods. Three thousand forty men with benign prostatic hyperplasia enrolled in the PLESS trial were randomly assigned to finasteride 5 mg or placebo for 4 years. Symptoms and flow rate were assessed every 4 months, and data were analyzed by dividing the patients into three groups by baseline PSA tertiles (0 to 1.3, 1.4 to 3.2, and 3.3 ng/mL or greater) and baseline prostate volume tertiles (14 to 41, 42 to 57, and 58 to 150 mL). Results. After the initial placebo effect, a slow deterioration in symptoms over time was observed in the placebo-treated men with a baseline PSA 1.4 ng/mL or greater. However, placebo-treated men in the lowest PSA tertile (less than 1.4 ng/mL) had sustained symptomatic improvement that was not seen in placebo-treated men in the higher tertiles ( P
ISSN:0090-4295
1527-9995
DOI:10.1016/S0090-4295(99)00232-0