Phase II Randomized Study of Soy Isoflavones in Patients With Localized Prostate Cancer Treated With Radiation Therapy
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:
OUTLINE: This is a randomized, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
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.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Other