Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia.
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.
Marshall
James R
JR
Roswell Park Cancer Institute, Buffalo, NY 14263, USA. james.marshall@roswellpark.org
Sakr
Wael
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Wood
David
D
Berry
Donna
D
Tangen
Catherine
C
Parker
Felicia
F
Thompson
Ian
I
Lippman
Scott M
SM
Lieberman
Ronald
R
Alberts
David
D
Jarrard
David
D
Coltman
Charles
C
Greenwald
Peter
P
Minasian
Lori
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Crawford
E David
ED
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
D016588:Anticarcinogenic Agents; D010919:Placebos; D012643:Selenium