Prostate Cancer Clinical Trial
Official title:
Phase II Randomized Study of Soy Isoflavones in Patients With Localized Prostate Cancer Treated With Radiation Therapy
RATIONALE: Eating a diet high in soy foods may slow the progression of some types of cancer.
Isoflavones are compounds found in soy food that may slow the growth of prostate cancer
cells and prevent further development of prostate cancer. Radiation therapy uses high-energy
x-rays to kill tumor cells. Giving isoflavones together with radiation therapy may be an
effective treatment for prostate cancer.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving
isoflavones together with radiation therapy works in treating patients with localized
prostate cancer.
OBJECTIVES:
- 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
treatment arms.
- 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
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