The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
OBJECTIVES:
- 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.
Interventional
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)
No
Nagi B. Kumar, PhD, RD, FADA
Study Chair
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
CDR0000069097
NCT00027950
October 2001
Name | Location |
---|---|
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 |