1981 UTILITY OF COMBINING FINAL PSA AND PSA DYNAMICS (CHANGE FROM MONTH 6 TO FINAL PSA) FOR PROSTATE CANCER AND HIGH GRADE CANCER DIAGNOSIS IN THE REDUCTION BY DUTASTERIDE OF PROSTATE CANCER EVENTS(REDUCE) STUDY

Abstract

You have accessJournal of UrologyProstate Cancer: Detection and Screening III1 Apr 20101981 UTILITY OF COMBINING FINAL PSA AND PSA DYNAMICS (CHANGE FROM MONTH 6 TO FINAL PSA) FOR PROSTATE CANCER AND HIGH GRADE CANCER DIAGNOSIS IN THE REDUCTION BY DUTASTERIDE OF PROSTATE CANCER EVENTS(REDUCE) STUDY Gerald L. Andriole, Stephen J. Freedland, Donald J. Tindall, Teuvo L.J. Tammela, Claudio Teloken, Matthew C. Somerville, Timothy H. Wilson, and Roger S. Rittmaster Gerald L. AndrioleGerald L. Andriole St Louis, MO More articles by this author , Stephen J. FreedlandStephen J. Freedland Durham, NC More articles by this author , Donald J. TindallDonald J. Tindall Rochester, MN More articles by this author , Teuvo L.J. TammelaTeuvo L.J. Tammela Tampere, Finland More articles by this author , Claudio TelokenClaudio Teloken Porto Alegre, Brazil More articles by this author , Matthew C. SomervilleMatthew C. Somerville Research Triangle Park, NC More articles by this author , Timothy H. WilsonTimothy H. Wilson Research Triangle Park, NC More articles by this author , and Roger S. RittmasterRoger S. Rittmaster Research Triangle Park, NC More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1992AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES REDUCE is a completed 4-year study of prostate cancer(PCa) risk reduction with dutasteride. This analysis examines the utility of both final PSA and changes in PSA from Month 6 to final PSA for the detection of PCa overall and Gleason 7-10 PCa(high-grade PCa). METHODS Eligible men were randomized to dutasteride or placebo for 4 years, were aged ≥50 and ≤75 years, had a serum PSA 2.5-10 ng/ml and had a single, negative biopsy of 6-12 cores within 6 months prior to enrollment. Transrectal ultrasound directed biopsies (10 cores) were taken at 2 and 4 years and examined for evidence of PCa. Area under the receiver operating curve(AUC) was calculated for the dutasteride and placebo groups using the final PSA before biopsy and separately the combination of final PSA and change in PSA from Month 6 to final PSA, with treatment groups being compared using a z test. RESULTS In the placebo group(n=3423) using final PSA, the AUC was 0.572 for any PCa and 0.650 for high-grade PCa. The AUC was unchanged by combining final PSA and change in PSA from Month 6(0.573 for any PCa and 0.649 for any high-grade PCa). In contrast, in the dutasteride group(n=3303), the AUC was 0.624 for any PCa and 0.700 for any high-grade PCa using final PSA(p=0.0017 and p=0.0487 versus placebo). These values increased to 0.657 for any PCa and 0.724 for any high-grade PCa when using both final PSA and change in PSA from Month 6(p<0.0001 and p=0.0030 versus placebo). CONCLUSIONS PSA is a significantly better predictor of prostate cancer on biopsy among men taking dutasteride than among men on placebo. In men treated with dutasteride, the combination of final PSA and change in PSA from nadir(Month 6) provided greater predictive value for PCa and high-grade PCa than final PSA alone. In the placebo group, the combination was no better than final PSA alone, probably because the value of PSA kinetics for PCa prediction was confounded by PSA increases from benign prostate tissue. Table. PCa and high-grade PCa incidence by final PSA and change in PSA in the dutasteride treatment group Final PSA before diagnosis Change in PSA from Month 6 to final PSA Overall PCa incidence High-grade PCa (Gleason 7–10) incidence ≤2.0 ng/ml ≤0 ng/ml 170/1312(13.0%) 39/1311(3.0%) >0 to ≤1 ng/ml 32/159(20.1%) 10/159(6.3%) > 1 ng/ml 0/3(0%) 0/3(0%) >2.0 to <>≤4 ng/ml ≤0 ng/ml 165/897(18.4%) 44/897(4.9%) >0 to ≤1 ng/ml 98/329(29.8%) 30/329(9.1%) > 1 ng/ml 27/81(33.3%) 14/81(17.3%) >4 ng/ml ≤0 ng/ml 28/119(23.5%) 10/119(8.4%) >0 to ≤1 ng/ml 42/103(40.8%) 21/102(20.6%) > 1 ng/ml 88/263(33.5%) 49/262(18.7%) © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e769 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Gerald L. Andriole St Louis, MO More articles by this author Stephen J. Freedland Durham, NC More articles by this author Donald J. Tindall Rochester, MN More articles by this author Teuvo L.J. Tammela Tampere, Finland More articles by this author Claudio Teloken Porto Alegre, Brazil More articles by this author Matthew C. Somerville Research Triangle Park, NC More articles by this author Timothy H. Wilson Research Triangle Park, NC More articles by this author Roger S. Rittmaster Research Triangle Park, NC More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...