The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
- Determine the effectiveness of isoflavones in producing a change in risk parameters,
such as decrease in free testosterone, increase in sex-hormone-binding globulin and
estradiol, and decrease in tumor progression and volume, as measured by decreasing
prostate-specific antigen in patients with stage I or II prostate cancer.
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to
Gleason score (2-4 vs 5-6). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral isoflavones twice daily and an oral multivitamin once
daily for 12 weeks.
- Arm II: Patients receive oral placebo twice daily and an oral multivitamin once daily
for 12 weeks.
PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study within 3 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Effect on prostate cancer risk parameters as measured by free testosterone, sex-hormone-binding globulin, estradiol, and prostate-specific antigen at baseline and post-study intervention (12 weeks)
Nagi B. Kumar, PhD, RD, FADA
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|CCOP - Western Regional, Arizona||Phoenix, Arizona 85006-2726|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||Tampa, Florida 33612|
|Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler||Savannah, Georgia 31405|