Phase II Randomized Study of Soy Isoflavones in Patients With Localized Prostate Cancer Treated With Radiation Therapy
- Determine the effect of soy protein isolate (isoflavones) and radiotherapy on the
modulation of biomarkers in patients with localized prostate cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the effect of this regimen on the quality of life of these patients.
OUTLINE: This is a randomized, placebo-controlled study. Patients are randomized to 1 of 2
- Arm I: Patients receive oral soy protein isolate (isoflavones) twice daily for 6 months
in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive an oral placebo twice daily for 6 months in the absence of
disease progression or unacceptable toxicity.
In both arms, patients also undergo radiotherapy while receiving isoflavones or placebo.
Quality of life is assessed periodically.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Oxidative DNA damage at 3 and 6 months
Omer Kucuk, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|