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

Claus G. Roehrborn, Peter Boyle, Donald Bergner, Todd Gray, Marc Gittelman, Thomas Shown, Arnold Melman, R. Bruce Bracken, Ralph De Vere White, Alice Taylor, Daniel Wang, Joanne Waldstreicher

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Abstract

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 <0.001). In all finasteride-treated groups, there was initial improvement followed by maintenance or continued symptom improvement over time (~3 to 3.5 points by the end of 4 years). The differences in symptom score improvement between placebo and finasteride were marginal for men with baseline PSA levels less than 1.4 ng/mL (P = 0.128) but were highly significant for men with PSA levels 1.4 ng/mL or greater (P <0.001). Urinary flow rate results were similar to those observed for symptoms. Analysis of symptom and flow rate data by prostate volume tertiles in a 10% subset of men yielded similar results, namely a deterioration of symptoms and flow rate in the two higher tertiles treated with placebo (greater than 41 mL) and a sustained improvement in all three groups of finasteride-treated patients. Conclusions. Baseline PSA and prostate volume are good predictors of long- term symptomatic and flow rate changes. Baseline PSA levels of 1.4 ng/mL or greater and enlarged prostate glands predict the best long-term response to finasteride compared with placebo.

Original languageEnglish (US)
Pages (from-to)662-669
Number of pages8
JournalUrology
Volume54
Issue number4
DOIs
StatePublished - Oct 1 1999

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ASJC Scopus subject areas

  • Urology

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Roehrborn, C. G., Boyle, P., Bergner, D., Gray, T., Gittelman, M., Shown, T., Melman, A., Bracken, R. B., White, R. D. V., Taylor, A., Wang, D., & Waldstreicher, J. (1999). 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. Urology, 54(4), 662-669. https://doi.org/10.1016/S0090-4295(99)00232-0