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The REDUCE Follow-Up Study: Low Rate of New Prostate Cancer Diagnoses Observed During a 2-Year, Observational, Followup Study of Men Who Participated in the REDUCE Trial

2012; Lippincott Williams & Wilkins; Volume: 189; Issue: 3 Linguagem: Inglês

10.1016/j.juro.2012.09.099

1527-3792

Robert L. Grubb, Gerald L. Andriole, Matthew C. Somerville, Chrysa Mahoney, Michael J. Manyak, Ramiro Castro,

Statistical Methods in Clinical Trials

No AccessJournal of UrologyAdult Urology1 Mar 2013The REDUCE Follow-Up Study: Low Rate of New Prostate Cancer Diagnoses Observed During a 2-Year, Observational, Followup Study of Men Who Participated in the REDUCE Trial Robert L. Grubb, Gerald L. Andriole, Matthew C. Somerville, Chrysa Mahoney, Michael J. Manyak, and Ramiro Castro Robert L. GrubbRobert L. Grubb Washington University School of Medicine in St. Louis, St. Louis, Missouri Financial interest and/or other relationship with GlaxoSmithKline and the National Cancer Institute. More articles by this author , Gerald L. AndrioleGerald L. Andriole Washington University School of Medicine in St. Louis, St. Louis, Missouri Financial interest and/or other relationship with Amarex LLC, Amgen, Augmenix, Bayer, Bristol Myers Squibb Co., Cambridge Endo, Caris, Envisioneering Medical, GlaxoSmithKline, Janssen Biotech Inc., Johnson & Johnson, Medivation, Myriad Genetics, Steba Biotech, Ortho-Clinical Diagnostics, Viking Medical and Wilex. More articles by this author , Matthew C. SomervilleMatthew C. Somerville GlaxoSmithKline, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , Chrysa MahoneyChrysa Mahoney GlaxoSmithKline, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , Michael J. ManyakMichael J. Manyak GlaxoSmithKline, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , and Ramiro CastroRamiro Castro GlaxoSmithKline R&D, King of Prussia, Pennsylvania Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.09.099AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: The primary objective of the REDUCE (REduction by DUtasteride of prostate Cancer Events) Follow-Up Study was to collect data on the occurrence of newly diagnosed prostate cancers for 2 years beyond the 4-year REDUCE study. Materials and Methods: The 4-year REDUCE study evaluated prostate cancer risk reduction in men taking dutasteride. This 2-year observational study followed men from REDUCE with a clinic visit shortly after study conclusion and with up to 2 annual telephone calls during which patient reported data were collected regarding prostate cancer events, chronic medication use, prostate specific antigen levels and serious adverse events. No study drug was provided and all biopsies during the 2-year followup were performed for cause. The primary objective was to collect data on the occurrence of new biopsy detectable prostate cancers. Secondary end points included assessment of Gleason score and serious adverse events. Results: A total of 2,751 men enrolled in the followup study with numbers similar to those of the REDUCE former treatment groups (placebo and dutasteride). Few new prostate cancers were detected during the 2-year followup period in either former treatment group. A greater number of cancers were detected in the former dutasteride group than in the former placebo group (14 vs 7 cases). No Gleason score 8–10 prostate cancers were detected in either former treatment group based on central pathology review. No new safety issues were identified during the study. Conclusions: Two years of followup of the REDUCE study cohort demonstrated a low rate of new prostate cancer diagnoses in the former placebo and dutasteride treated groups. No new Gleason 8–10 cancers were detected. 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Google Scholar © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byKaplan S (2020) Re: Impact of 5α-Reductase Inhibitor and α-Blocker Therapy for Benign Prostatic Hyperplasia on Prostate Cancer Incidence and MortalityJournal of Urology, VOL. 203, NO. 5, (856-857), Online publication date: 1-May-2020.Steers W (2012) This Month in Adult UrologyJournal of Urology, VOL. 189, NO. 3, (787-788), Online publication date: 1-Mar-2013. Volume 189Issue 3March 2013Page: 871-877 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.Keywordsdutasterideprostatic neoplasmsdiagnosisbiopsyneoplasm gradingAcknowledgmentsEditorial support was provided by Ronnie Henderson (Choice Healthcare Solutions, London, United Kingdom) and was funded by GlaxoSmithKline.MetricsAuthor Information Robert L. Grubb Washington University School of Medicine in St. Louis, St. Louis, Missouri Financial interest and/or other relationship with GlaxoSmithKline and the National Cancer Institute. More articles by this author Gerald L. Andriole Washington University School of Medicine in St. Louis, St. Louis, Missouri Financial interest and/or other relationship with Amarex LLC, Amgen, Augmenix, Bayer, Bristol Myers Squibb Co., Cambridge Endo, Caris, Envisioneering Medical, GlaxoSmithKline, Janssen Biotech Inc., Johnson & Johnson, Medivation, Myriad Genetics, Steba Biotech, Ortho-Clinical Diagnostics, Viking Medical and Wilex. More articles by this author Matthew C. Somerville GlaxoSmithKline, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Chrysa Mahoney GlaxoSmithKline, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Michael J. Manyak GlaxoSmithKline, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Ramiro Castro GlaxoSmithKline R&D, King of Prussia, Pennsylvania Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Expand All Advertisement PDF downloadLoading ...