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Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia.

Abstract
High-grade prostatic intraepithelial neoplasia (HGPIN) is generally regarded as a premalignant lesion that progresses toward prostate cancer. In light of the significant sequelae of prostate cancer treatment, prevention is desirable, and men with HGPIN would be suitable, high-risk subjects. There is in vitro, in vivo, epidemiologic, and human experimental evidence that selenium supplementation may protect against prostate cancer. This article introduces the rationale for, and progress to date, of a double-blind, randomized, placebo-controlled trial of selenium supplementation (200 mug/d in the form of selenomethionine), to prevent the development of prostate cancer among men with HGPIN. The trial, Southwest Oncology Group Protocol 9917, funded by a National Cancer Institute program supporting pivotal prevention trials has registered 537 patients and has randomized >380 to date. Subject accrual is expected to be completed by the fall of 2006, with trial completion in 2009.
AuthorsJames R Marshall, Wael Sakr, David Wood, Donna Berry, Catherine Tangen, Felicia Parker, Ian Thompson, Scott M Lippman, Ronald Lieberman, David Alberts, David Jarrard, Charles Coltman, Peter Greenwald, Lori Minasian, E David Crawford
JournalCancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology (Cancer Epidemiol Biomarkers Prev) Vol. 15 Issue 8 Pg. 1479-84 (Aug 2006) ISSN: 1055-9965 [Print] United States
PMID16896036 (Publication Type: Journal Article, Randomized Controlled Trial)
Chemical References
  • Anticarcinogenic Agents
  • Placebos
  • Selenium
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Anticarcinogenic Agents (therapeutic use)
  • Clinical Trials as Topic (methods)
  • Dietary Supplements
  • Double-Blind Method
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Placebos
  • Prostatic Intraepithelial Neoplasia (epidemiology, prevention & control)
  • Prostatic Neoplasms (epidemiology, prevention & control)
  • Research Design
  • Selenium (administration & dosage, blood)

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