Phase III Trial of Selenium to Prevent Prostate Cancer in Men with High-grade Prostatic Intraepithelial Neoplasia: SWOG S9917
Year: 2011
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: The threat of prostate cancer and the significant and often negative impact of its treatment underscore the importance of prevention. High-grade prostatic intraepithelial neoplasia (HGPIN) has been identified as a potential premalignant lesion marking an increased risk of prostate cancer and substantial evidence suggests that men with HGPIN are in need of prostate cancer prevention. In vitro, in vivo, epidemiologic, and clinical trial evidence that selenium supplementation protects against prostate cancer motivated the study we report here: a double-blind, randomized, placebo-controlled trial of selenium 200 (μg/d) as selenomethionine in men with HGPIN. The primary endpoint was progression of HGPIN to prostate cancer over a 3-year period. This National Cancer Institute Intergroup trial was coordinated by the Southwest Oncology Group (SWOG). Of 619 enrolled patients, 423 randomized men with HGPIN (212 selenium and 211 placebo) were eligible (by central pathology review) and included in the primary analysis. Three-year cancer rates were 36.6% (placebo) versus 35.6% (selenium; P = 0.73, adjusted). The majority of patients who developed cancer on trial (70.8%, selenium and 75.5%, placebo) had a Gleason score of 6 or less than 6; there were no differences in Gleason scores between the two arms. Subset analyses included the finding of a nonsignificantly reduced prostate cancer risk (relative risk = 0.82; 95% CI: 0.40-1.69) in selenium versus placebo patients in the lowest quartile of baseline plasma selenium level (<106 ng/mL). Overall, and in all other subsets defined by baseline blood selenium levels, selenium supplementation had no effect on prostate cancer risk. The 36% prostate cancer rate in men with HGPIN indicates the association of this lesion with an elevated prostate cancer risk. Future study in this setting should focus on selenium-deficient populations and selenium pharmacogenetics.
Source: Cancer Prevention Research
Authors: James R. Marshall, Catherine M. Tangen, Wael A. Sakr, David P. Wood, Donna L. Berry, Eric A. Klein, Scott M. Lippman, Howard L. Parnes, David S. Alberts, David F. Jarrard, W. Robert Lee, J. Michael Gaziano, E. David Crawford, Benjamin Ely, Michael Ray, Warren Davis, Lori M. Minasian, Ian M. Thompson
Language: English
Subfield: Nutrition and Dietetics
Field: Nursing
Domain: Health Sciences
Open Access status: green
Awards: G1033243903, G1216887118, G1257575315, G1331445602, G1375689152, Columbus Community Clinical Oncology Program (Columbus CCOP), G1545560008, U10 Full Member Application Affiliated with SWOG, G1646027999, G1790576020, G1794831901, G1958973285, G20028727, G2043432835, G2057923966, Scott & White Community Clinical Oncology Program, G2160369479, G2201816905, G2223902704, G2237949143, G2276667821, G2320693132, G2345882982, G2419449687, G2435896781, G2485941414, G2562936776, G2646278872, G2679961467, G268786457, G2750730928, COLUMBIA UNIVERSITY SOUTHWEST ONCOLOGY GROUP PROGRAM, Ozark Health Ventures, LLC dba Cancer Research for the Ozarks, GRAND RAPIDS CLINICAL ONCOLOGY PROGRAM, SOUTHWEST ONCOLOGY GROUP STATISTICAL CENTER, G3126600779, G313314762, G3144944009, G3239274266, G3242537740, G3295642875, G3337849518, G3484997517, G3521018462, City of Hope Southwest Oncology Group Clinical Trials, G36541222, G3737421695, G379387698, G3827208107, G3939550896, Cancer and Leukemia Group B: RPCI/SUNYAB, G4110529384, G425646771, G4271794948, Southwest Oncology Group, G4292856267, G444114835, Southwest Oncology Group, G4527800867, G4719029039, G5187432406, G5264753430, G5566132837, G6211207823, SOUTHWEST ONCOLOGY GROUP, G6782300252, G6943608702, G7222907299, G7230571265, CENTRAL ILLINOIS COMMUNITY CLINICAL ONCOLOGY PROGRAM, G758084519, Virginia Mason Community Clinical Oncology Program, G7926913928, G8116866424, G8156375866, Eastern Cooperative Oncology Group Operations Office, G8267978893, G860872252, G869916006, G8740717309, G886666726, PARTICIPATE AS MEMBER OF SOUTHWEST ONCOLOGY GROUP, G8937348795, G8999593589, G964706321, G991892531
OpenAlex ID: W2159529650