title: 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.
authors.affiliation: Roswell Park Cancer Institute, Buffalo, NY 14263, USA. james.marshall@roswellpark.org
authors.forename: James R
authors.initials: JR
authors.lastname: Marshall
authors.forename: Wael
authors.initials: W
authors.lastname: Sakr
authors.forename: David
authors.initials: D
authors.lastname: Wood
authors.forename: Donna
authors.initials: D
authors.lastname: Berry
authors.forename: Catherine
authors.initials: C
authors.lastname: Tangen
authors.forename: Felicia
authors.initials: F
authors.lastname: Parker
authors.forename: Ian
authors.initials: I
authors.lastname: Thompson
authors.forename: Scott M
authors.initials: SM
authors.lastname: Lippman
authors.forename: Ronald
authors.initials: R
authors.lastname: Lieberman
authors.forename: David
authors.initials: D
authors.lastname: Alberts
authors.forename: David
authors.initials: D
authors.lastname: Jarrard
authors.forename: Charles
authors.initials: C
authors.lastname: Coltman
authors.forename: Peter
authors.initials: P
authors.lastname: Greenwald
authors.forename: Lori
authors.initials: L
authors.lastname: Minasian
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016588:Anticarcinogenic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D019587:Dietary Supplements; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010919:Placebos; D019048:Prostatic Intraepithelial Neoplasia / Q000453:epidemiology / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000453:epidemiology / Q000517:prevention & control*; D012107:Research Design; D012643:Selenium / Q000008:administration & dosage* / Q000097:blood
chemical_list: D016588:Anticarcinogenic Agents; D010919:Placebos; D012643:Selenium