Diet is presumed to play a major role in prostate cancer - a leading cancer among American men. Yet, to date there are no dietary interventions with proven efficacy for either prevention or complementary care. The proposed study will focus on flaxseed supplementation (FS) and a low fat diet (LF), since our pilot studies and the research of others suggest that these factors significantly alter prostate cancer progression. Our multidisciplinary team of nutritionists, urologists, pathologists and biostatistians propose a controlled clinical trial to test the effects of FS and LF on prostatic neoplasia and also explore potential hormonal mechanisms. Newly diagnosed, prostate cancer cases (N=160) who have greater than 3-week lag- time prior to prostatectomy will be block randomized into one of the following groups: 1) control; 2) FS (30 g/day); LF (less than or equal to 20 percent total energy); or 4) FS+LF. All subjects will be monitored and receive dietary instruction and supplies. Proliferation rate (MIB-1) will serve as the primary endpoint to determine diet efficacy. Other endpoints include: apoptotic index (TUNEL), extent of high grade prostatic intraepithelial neoplasia and total serum prostate specific antigen. Given our pilot data which suggest that FS and LF diets may operate via a hormonal mechanism, potential hormonal mediators also will be assessed [i.e., total serum testosterone, free androgen index, insulin-like growth factor-1 (IGF-1) and IGF binding protein-3]. Nutritional biomarkers (i.e., lignan levels in prostatic fluid and urine, and erythrocyte and prostate fatty acid profiles) also will be measured. Associations between nutritional biomarkers, hormonal mediators and study endpoints will be determined. The proposed study is structured to make an important contribution to what is known about diet and prostatic neoplasia. This research has the potential to expand the scope of complementary treatment offered for prostate cancer, and may provide a solid foundation for efforts aimed at prevention.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA085740-03
Application #
6698051
Study Section
Metabolic Pathology Study Section (MEP)
Program Officer
Kim, Young Shin
Project Start
2002-01-04
Project End
2005-12-31
Budget Start
2004-01-01
Budget End
2004-12-31
Support Year
3
Fiscal Year
2004
Total Cost
$307,686
Indirect Cost
Name
Duke University
Department
Surgery
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Demark-Wahnefried, Wendy (2017) Response to: systematic review of dietary, nutritional, and physical activity interventions for the prevention of prostate cancer progression and mortality by Hackshaw-McGeagh and Colleagues. Cancer Causes Control 28:905
Zhang, Daniel Y; Azrad, Maria; Demark-Wahnefried, Wendy et al. (2015) Peptide-based, two-fluorophore, ratiometric probe for quantifying mobile zinc in biological solutions. ACS Chem Biol 10:385-9
Azrad, M; Vollmer, R T; Madden, J et al. (2015) Disparate results between proliferation rates of surgically excised prostate tumors and an in vitro bioassay using sera from a positive randomized controlled trial. Biotech Histochem 90:184-9
Azrad, Maria; Vollmer, Robin T; Madden, John et al. (2013) Flaxseed-derived enterolactone is inversely associated with tumor cell proliferation in men with localized prostate cancer. J Med Food 16:357-60
Azrad, Maria; Zhang, Kui; Vollmer, Robin T et al. (2012) Prostatic alpha-linolenic acid (ALA) is positively associated with aggressive prostate cancer: a relationship which may depend on genetic variation in ALA metabolism. PLoS One 7:e53104
Azrad, Maria; Demark-Wahnefried, Wendy (2012) Dietary omega-6 and omega-3 fatty acids and prostate cancer - letter. Cancer Prev Res (Phila) 5:798; author reply 799
Heymach, John V; Shackleford, Terry J; Tran, Hai T et al. (2011) Effect of low-fat diets on plasma levels of NF-?B-regulated inflammatory cytokines and angiogenic factors in men with prostate cancer. Cancer Prev Res (Phila) 4:1590-8
Wu, Hongyu; Pan, An; Yu, Zhijie et al. (2010) Lifestyle counseling and supplementation with flaxseed or walnuts influence the management of metabolic syndrome. J Nutr 140:1937-42
Pan, An; Yu, Danxia; Demark-Wahnefried, Wendy et al. (2009) Meta-analysis of the effects of flaxseed interventions on blood lipids. Am J Clin Nutr 90:288-97
Mavropoulos, John C; Buschemeyer 3rd, W Cooper; Tewari, Alok K et al. (2009) The effects of varying dietary carbohydrate and fat content on survival in a murine LNCaP prostate cancer xenograft model. Cancer Prev Res (Phila) 2:557-65

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