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 DeVere White, Alice Taylor, Daniel Wang, Joanne Waldstreicher

Research output: Contribution to journalArticle

169 Citations (Scopus)

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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Finasteride
Prostate-Specific Antigen
Prostate
Placebos
Serum
Placebo Effect
Prostatic Hyperplasia
Maintenance

ASJC Scopus subject areas

  • Urology

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

In: Urology, Vol. 54, No. 4, 10.1999, p. 662-669.

Research output: Contribution to journalArticle

Roehrborn, CG, Boyle, P, Bergner, D, Gray, T, Gittelman, M, Shown, T, Melman, A, Bracken, RB, White, RD, 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, vol. 54, no. 4, pp. 662-669. https://doi.org/10.1016/S0090-4295(99)00232-0
Roehrborn, Claus G. ; Boyle, Peter ; Bergner, Donald ; Gray, Todd ; Gittelman, Marc ; Shown, Thomas ; Melman, Arnold ; Bracken, R. Bruce ; White, Ralph DeVere ; Taylor, Alice ; Wang, Daniel ; Waldstreicher, Joanne. / 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. In: Urology. 1999 ; Vol. 54, No. 4. pp. 662-669.
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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.",
author = "Roehrborn, {Claus G.} and Peter Boyle and Donald Bergner and Todd Gray and Marc Gittelman and Thomas Shown and Arnold Melman and Bracken, {R. Bruce} and White, {Ralph DeVere} and Alice Taylor and Daniel Wang and Joanne Waldstreicher",
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T1 - Serum prostate-specific antigen and prostate volume predict long-term changes in symptoms and flow rate

T2 - Results of a four-year, randomized trial comparing finasteride versus placebo

AU - Roehrborn, Claus G.

AU - Boyle, Peter

AU - Bergner, Donald

AU - Gray, Todd

AU - Gittelman, Marc

AU - Shown, Thomas

AU - Melman, Arnold

AU - Bracken, R. Bruce

AU - White, Ralph DeVere

AU - Taylor, Alice

AU - Wang, Daniel

AU - Waldstreicher, Joanne

PY - 1999/10

Y1 - 1999/10

N2 - 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.

AB - 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.

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