The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy: Results from the REDUCE study

Gerald L. Andriole, David Bostwick, Otis W. Brawley, Leonard Gomella, Michael Marberger, Francesco Montorsi, Curtis Pettaway, Teuvo L J Tammela, Claudio Teloken, Donald Tindall, Stephen J. Freedland, Matthew C. Somerville, Timothy H. Wilson, Ivy Fowler, Ramiro Castro, Roger S. Rittmaster

Research output: Contribution to journalArticle

63 Citations (Scopus)

Abstract

Purpose We assessed whether dutasteride enhances the usefulness of total prostate specific antigen for diagnosing clinically significant prostate cancer. Materials and Methods The 4-year REDUCE study evaluated the efficacy and safety of 0.5 mg dutasteride daily for prostate cancer risk reduction in men with a prostate specific antigen of 2.5 to 10.0 ng/ml and a negative prostate biopsy. Specificity, sensitivity, and positive and negative predictive values of prostate specific antigen for the diagnosis of prostate cancer were assessed. Results Final prostate specific antigen before biopsy and change from month 6 to final prostate specific antigen performed better for the diagnosis of Gleason score 710 tumors in men who received dutasteride vs placebo as assessed by the area under the ROC curves (0.700 vs 0.650, p = 0.0491; and 0.699 vs 0.593, p = 0.0001, respectively). Increases in prostate specific antigen were associated with a higher likelihood of biopsy detectable, Gleason score 710 and clinically significant (modified Epstein criteria) prostate cancer. Percentage decreases in prostate specific antigen from baseline to month 6 in the dutasteride arm did not predict prostate cancer overall or Gleason score 710 cancer. Conclusions In men with a previously negative prostate biopsy, prostate specific antigen performed better during the 4-year study as a marker of prostate cancer in men who received dutasteride vs placebo. The degree of prostate specific antigen increase after 6 months was a better indicator of clinically significant cancer in the dutasteride arm than in the placebo arm. Conversely, the initial decrease in prostate specific antigen in men taking dutasteride did not predict the likelihood of prostate cancer.

Original languageEnglish (US)
Pages (from-to)126-131
Number of pages6
JournalJournal of Urology
Volume185
Issue number1
DOIs
StatePublished - Jan 2011

Fingerprint

Prostate-Specific Antigen
Prostatic Neoplasms
Biopsy
Neoplasm Grading
Placebos
Prostate
Dutasteride
Neoplasms
Risk Reduction Behavior
ROC Curve
Area Under Curve
Safety
Sensitivity and Specificity

Keywords

  • Dutasteride
  • Prostate-specific antigen
  • Prostatic neoplasms
  • Sensitivity and specificity

ASJC Scopus subject areas

  • Urology

Cite this

The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy : Results from the REDUCE study. / Andriole, Gerald L.; Bostwick, David; Brawley, Otis W.; Gomella, Leonard; Marberger, Michael; Montorsi, Francesco; Pettaway, Curtis; Tammela, Teuvo L J; Teloken, Claudio; Tindall, Donald; Freedland, Stephen J.; Somerville, Matthew C.; Wilson, Timothy H.; Fowler, Ivy; Castro, Ramiro; Rittmaster, Roger S.

In: Journal of Urology, Vol. 185, No. 1, 01.2011, p. 126-131.

Research output: Contribution to journalArticle

Andriole, GL, Bostwick, D, Brawley, OW, Gomella, L, Marberger, M, Montorsi, F, Pettaway, C, Tammela, TLJ, Teloken, C, Tindall, D, Freedland, SJ, Somerville, MC, Wilson, TH, Fowler, I, Castro, R & Rittmaster, RS 2011, 'The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy: Results from the REDUCE study', Journal of Urology, vol. 185, no. 1, pp. 126-131. https://doi.org/10.1016/j.juro.2010.09.011
Andriole, Gerald L. ; Bostwick, David ; Brawley, Otis W. ; Gomella, Leonard ; Marberger, Michael ; Montorsi, Francesco ; Pettaway, Curtis ; Tammela, Teuvo L J ; Teloken, Claudio ; Tindall, Donald ; Freedland, Stephen J. ; Somerville, Matthew C. ; Wilson, Timothy H. ; Fowler, Ivy ; Castro, Ramiro ; Rittmaster, Roger S. / The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy : Results from the REDUCE study. In: Journal of Urology. 2011 ; Vol. 185, No. 1. pp. 126-131.
@article{d19d56555b4e47429d3f9507c1d69c88,
title = "The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy: Results from the REDUCE study",
abstract = "Purpose We assessed whether dutasteride enhances the usefulness of total prostate specific antigen for diagnosing clinically significant prostate cancer. Materials and Methods The 4-year REDUCE study evaluated the efficacy and safety of 0.5 mg dutasteride daily for prostate cancer risk reduction in men with a prostate specific antigen of 2.5 to 10.0 ng/ml and a negative prostate biopsy. Specificity, sensitivity, and positive and negative predictive values of prostate specific antigen for the diagnosis of prostate cancer were assessed. Results Final prostate specific antigen before biopsy and change from month 6 to final prostate specific antigen performed better for the diagnosis of Gleason score 710 tumors in men who received dutasteride vs placebo as assessed by the area under the ROC curves (0.700 vs 0.650, p = 0.0491; and 0.699 vs 0.593, p = 0.0001, respectively). Increases in prostate specific antigen were associated with a higher likelihood of biopsy detectable, Gleason score 710 and clinically significant (modified Epstein criteria) prostate cancer. Percentage decreases in prostate specific antigen from baseline to month 6 in the dutasteride arm did not predict prostate cancer overall or Gleason score 710 cancer. Conclusions In men with a previously negative prostate biopsy, prostate specific antigen performed better during the 4-year study as a marker of prostate cancer in men who received dutasteride vs placebo. The degree of prostate specific antigen increase after 6 months was a better indicator of clinically significant cancer in the dutasteride arm than in the placebo arm. Conversely, the initial decrease in prostate specific antigen in men taking dutasteride did not predict the likelihood of prostate cancer.",
keywords = "Dutasteride, Prostate-specific antigen, Prostatic neoplasms, Sensitivity and specificity",
author = "Andriole, {Gerald L.} and David Bostwick and Brawley, {Otis W.} and Leonard Gomella and Michael Marberger and Francesco Montorsi and Curtis Pettaway and Tammela, {Teuvo L J} and Claudio Teloken and Donald Tindall and Freedland, {Stephen J.} and Somerville, {Matthew C.} and Wilson, {Timothy H.} and Ivy Fowler and Ramiro Castro and Rittmaster, {Roger S.}",
year = "2011",
month = "1",
doi = "10.1016/j.juro.2010.09.011",
language = "English (US)",
volume = "185",
pages = "126--131",
journal = "Journal of Urology",
issn = "0022-5347",
publisher = "Elsevier Inc.",
number = "1",

}

TY - JOUR

T1 - The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy

T2 - Results from the REDUCE study

AU - Andriole, Gerald L.

AU - Bostwick, David

AU - Brawley, Otis W.

AU - Gomella, Leonard

AU - Marberger, Michael

AU - Montorsi, Francesco

AU - Pettaway, Curtis

AU - Tammela, Teuvo L J

AU - Teloken, Claudio

AU - Tindall, Donald

AU - Freedland, Stephen J.

AU - Somerville, Matthew C.

AU - Wilson, Timothy H.

AU - Fowler, Ivy

AU - Castro, Ramiro

AU - Rittmaster, Roger S.

PY - 2011/1

Y1 - 2011/1

N2 - Purpose We assessed whether dutasteride enhances the usefulness of total prostate specific antigen for diagnosing clinically significant prostate cancer. Materials and Methods The 4-year REDUCE study evaluated the efficacy and safety of 0.5 mg dutasteride daily for prostate cancer risk reduction in men with a prostate specific antigen of 2.5 to 10.0 ng/ml and a negative prostate biopsy. Specificity, sensitivity, and positive and negative predictive values of prostate specific antigen for the diagnosis of prostate cancer were assessed. Results Final prostate specific antigen before biopsy and change from month 6 to final prostate specific antigen performed better for the diagnosis of Gleason score 710 tumors in men who received dutasteride vs placebo as assessed by the area under the ROC curves (0.700 vs 0.650, p = 0.0491; and 0.699 vs 0.593, p = 0.0001, respectively). Increases in prostate specific antigen were associated with a higher likelihood of biopsy detectable, Gleason score 710 and clinically significant (modified Epstein criteria) prostate cancer. Percentage decreases in prostate specific antigen from baseline to month 6 in the dutasteride arm did not predict prostate cancer overall or Gleason score 710 cancer. Conclusions In men with a previously negative prostate biopsy, prostate specific antigen performed better during the 4-year study as a marker of prostate cancer in men who received dutasteride vs placebo. The degree of prostate specific antigen increase after 6 months was a better indicator of clinically significant cancer in the dutasteride arm than in the placebo arm. Conversely, the initial decrease in prostate specific antigen in men taking dutasteride did not predict the likelihood of prostate cancer.

AB - Purpose We assessed whether dutasteride enhances the usefulness of total prostate specific antigen for diagnosing clinically significant prostate cancer. Materials and Methods The 4-year REDUCE study evaluated the efficacy and safety of 0.5 mg dutasteride daily for prostate cancer risk reduction in men with a prostate specific antigen of 2.5 to 10.0 ng/ml and a negative prostate biopsy. Specificity, sensitivity, and positive and negative predictive values of prostate specific antigen for the diagnosis of prostate cancer were assessed. Results Final prostate specific antigen before biopsy and change from month 6 to final prostate specific antigen performed better for the diagnosis of Gleason score 710 tumors in men who received dutasteride vs placebo as assessed by the area under the ROC curves (0.700 vs 0.650, p = 0.0491; and 0.699 vs 0.593, p = 0.0001, respectively). Increases in prostate specific antigen were associated with a higher likelihood of biopsy detectable, Gleason score 710 and clinically significant (modified Epstein criteria) prostate cancer. Percentage decreases in prostate specific antigen from baseline to month 6 in the dutasteride arm did not predict prostate cancer overall or Gleason score 710 cancer. Conclusions In men with a previously negative prostate biopsy, prostate specific antigen performed better during the 4-year study as a marker of prostate cancer in men who received dutasteride vs placebo. The degree of prostate specific antigen increase after 6 months was a better indicator of clinically significant cancer in the dutasteride arm than in the placebo arm. Conversely, the initial decrease in prostate specific antigen in men taking dutasteride did not predict the likelihood of prostate cancer.

KW - Dutasteride

KW - Prostate-specific antigen

KW - Prostatic neoplasms

KW - Sensitivity and specificity

UR - http://www.scopus.com/inward/record.url?scp=78649997059&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=78649997059&partnerID=8YFLogxK

U2 - 10.1016/j.juro.2010.09.011

DO - 10.1016/j.juro.2010.09.011

M3 - Article

C2 - 21074214

AN - SCOPUS:78649997059

VL - 185

SP - 126

EP - 131

JO - Journal of Urology

JF - Journal of Urology

SN - 0022-5347

IS - 1

ER -