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.
N1 - Funding Information:
Editorial support was provided by Alexander Gray at Idea Pharma, and Meredith Kalish and Elaine Bell at Choice Pharma, and was funded by GlaxoSmithKline .
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
U2 - 10.1016/j.juro.2010.09.011
DO - 10.1016/j.juro.2010.09.011
M3 - Article
C2 - 21074214
AN - SCOPUS:78649997059
SN - 0022-5347
VL - 185
SP - 126
EP - 131
JO - Journal of Urology
JF - Journal of Urology
IS - 1
ER -