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Toremifene for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia: Results of a Double-Blind, Placebo Controlled, Phase IIB Clinical Trial

2006; Lippincott Williams & Wilkins; Volume: 176; Issue: 3 Linguagem: Inglês

10.1016/j.juro.2006.04.011

1527-3792

David T. Price, Barry Stein, Paul Sieber, Ronald Tutrone, James L. Bailen, Erik T. Goluboff, Daniel Burzon, David G. Bostwick, Mitchell S. Steiner,

Estrogen and related hormone effects

No AccessJournal of UrologyAdult urology1 Sep 2006Toremifene for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia: Results of a Double-Blind, Placebo Controlled, Phase IIB Clinical Trial David Price, Barry Stein, Paul Sieber, Ronald Tutrone, James Bailen, Erik Goluboff, Daniel Burzon, David Bostwick, Mitchell Steiner, and GTx-006-221 Study Team David PriceDavid Price Regional Urology L. L. C., Shreveport, Louisiana More articles by this author , Barry SteinBarry Stein University Urological Associates, Inc., Providence, Rhode Island More articles by this author , Paul SieberPaul Sieber Urology Associates of Lancaster, Lancaster, Pennsylvania More articles by this author , Ronald TutroneRonald Tutrone Chesapeake Urology Associates, Baltimore, Maryland More articles by this author , James BailenJames Bailen Metropolitan Urology, P. S. C., Jeffersonville, Indiana More articles by this author , Erik GoluboffErik Goluboff Department of Urology, Columbia University, New York, New York More articles by this author , Daniel BurzonDaniel Burzon Coastal Urology Associates, Brick, New Jersey More articles by this author , David BostwickDavid Bostwick Bostwick Laboratories, Richmond, Virginia More articles by this author , Mitchell SteinerMitchell Steiner GTx, Inc., Memphis, Tennessee More articles by this author , and GTx-006-221 Study Team More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2006.04.011AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: A randomized, double-blind, dose finding, placebo controlled, parallel group clinical study was done to determine the incidence of prostate cancer in men with high grade prostatic intraepithelial neoplasia treated with toremifene. Materials and Methods: A total of 514 patients with high grade prostatic intraepithelial neoplasia and no evidence of prostate cancer on screening biopsy were randomized to 20, 40 or 60 mg toremifene, or placebo daily for 12 months. Patients underwent re-biopsy at 6 and 12 months. Results: The number of evaluable patients, that is those with 1 on study biopsy who were compliant, was 447. The cumulative risk of prostate cancer was decreased in patients on 20 mg toremifene compared with placebo (24.4% vs 31.2%, p <0.05). The annualized rate of prevention was 6.8 cancers per 100 men treated. In patients with no biopsy evidence of cancer at baseline and 6 months, the 12-month incidence of prostate cancer was decreased by 48.2% with 20 mg toremifene compared with placebo (9.1% vs 17.4%, p <0.05). The 20 mg dose was most effective but cumulative and 12-month incidences of prostate cancer were lower for each toremifene dose vs placebo with a cumulative risk of 29.2% and 28.1%, and a 12-month incidence of 14.3% and 13.0% for 40 and 60 mg, respectively. Gleason scores were similar across treatments. The overall incidence of drug related and serious adverse events did not differ between any of the toremifene groups and the placebo group. Conclusions: Toremifene decreased the incidence of prostate cancer by 1 year and had a tolerability profile comparable to that of placebo in a high risk population. References 1 : Evolution of isolated high-grade prostate intraepithelial neoplasia in a Mediterranean patient population. Eur Urol1999; 35: 496. Google Scholar 2 : Effect of neoadjuvant hormonal therapy on prostatic intraepithelial neoplasia and its prognostic significance. J Urol1999; 162: 753. 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Link, Google Scholar © 2006 by American Urological AssociationFiguresReferencesRelatedDetailsCited byLee M, Moussa A, Yu C, Kattan M, Magi-Galluzzi C and Jones J (2010) Multifocal High Grade Prostatic Intraepithelial Neoplasia is a Risk Factor for Subsequent Prostate CancerJournal of Urology, VOL. 184, NO. 5, (1958-1962), Online publication date: 1-Nov-2010.Celhay O, Yacoub M, Irani J, Dore B, Cussenot O and Fromont G (2010) Expression of Estrogen Related Proteins in Hormone Refractory Prostate Cancer: Association With Tumor ProgressionJournal of Urology, VOL. 184, NO. 5, (2172-2178), Online publication date: 1-Nov-2010.Thompson I, Tangen C, Goodman P, Lucia M and Klein E (2009) Chemoprevention of Prostate CancerJournal of Urology, VOL. 182, NO. 2, (499-508), Online publication date: 1-Aug-2009.Thompson I (2007) Chemoprevention of Prostate Cancer: Agents and Study DesignsJournal of Urology, VOL. 178, NO. 3S, (S9-S13), Online publication date: 1-Sep-2007.Lotan Y (2007) Editorial CommentJournal of Urology, VOL. 178, NO. 1, (110-110), Online publication date: 1-Jul-2007. Volume 176Issue 3September 2006Page: 965-971 Advertisement Copyright & Permissions© 2006 by American Urological AssociationKeywordsprostatic neoplasmsprostatic intraepithelial neoplasiatoremifeneselective estrogen receptor modulatorsestrogensAcknowledgmentsJane Saiers assisted with the manuscript.MetricsAuthor Information David Price Regional Urology L. L. C., Shreveport, Louisiana More articles by this author Barry Stein University Urological Associates, Inc., Providence, Rhode Island More articles by this author Paul Sieber Urology Associates of Lancaster, Lancaster, Pennsylvania More articles by this author Ronald Tutrone Chesapeake Urology Associates, Baltimore, Maryland More articles by this author James Bailen Metropolitan Urology, P. S. C., Jeffersonville, Indiana More articles by this author Erik Goluboff Department of Urology, Columbia University, New York, New York More articles by this author Daniel Burzon Coastal Urology Associates, Brick, New Jersey More articles by this author David Bostwick Bostwick Laboratories, Richmond, Virginia More articles by this author Mitchell Steiner GTx, Inc., Memphis, Tennessee More articles by this author GTx-006-221 Study Team More articles by this author Expand All Advertisement PDF downloadLoading ...