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 language | English (US) |
|---|---|
| Pages (from-to) | 662-669 |
| Number of pages | 8 |
| Journal | Urology |
| Volume | 54 |
| Issue number | 4 |
| DOIs | |
| State | Published - Oct 1999 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Urology
Cite this
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; deVere White, Ralph W; Taylor, Alice; Wang, Daniel; Waldstreicher, Joanne.
In: Urology, Vol. 54, No. 4, 10.1999, p. 662-669.Research output: Contribution to journal › Article
}
TY - JOUR
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 - deVere White, Ralph W
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.
UR - http://www.scopus.com/inward/record.url?scp=0032868620&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032868620&partnerID=8YFLogxK
U2 - 10.1016/S0090-4295(99)00232-0
DO - 10.1016/S0090-4295(99)00232-0
M3 - Article
VL - 54
SP - 662
EP - 669
JO - Urology
JF - Urology
SN - 1527-9995
IS - 4
ER -