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 W deVere White, Alice Taylor, Daniel Wang, Joanne Waldstreicher

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170 Scopus citations

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 1999
Externally publishedYes

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ASJC Scopus subject areas

  • Urology

Cite this

Roehrborn, C. G., Boyle, P., Bergner, D., Gray, T., Gittelman, M., Shown, T., Melman, A., Bracken, R. B., deVere White, R. W., 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