A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
- Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on
intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients
with localized prostate cancer.
- Compare the effects of these nutritional supplements on increases in plasma levels and
tissue levels of these agents in these patients.
- Compare the effects of these nutritional supplements on changes in surrogate markers of
disease progression (e.g., prostate-specific antigen levels) in these patients.
- Compare the effects of these nutritional supplements on changes in serum steroid
hormones, estradiol, and free testosterone in these patients.
- Compare the magnitude of these changes in patients treated with these nutritional
supplements vs patients in the control group.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial
neoplasia. Patients are randomized to 1 of 7 treatment groups.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Occurrences of Treatment Effect on Biomarkers in Each Group
Effect of isoflavones and lycopene on endpoint biomarkers as measured by tissue cell proliferation, apoptosis, or programmed cell death at prostate cancer biopsy and surgical excision
Nagi B. Kumar, PhD, RD, FADA
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|CCOP - MeritCare Hospital||Fargo, North Dakota 58122|
|CCOP - Western Regional, Arizona||Phoenix, Arizona 85006-2726|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler||Savannah, Georgia 31405|