Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage II prostate cancer
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTsoy protein isolate
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate that is localized to the prostate gland * Must be scheduled to receive curative radiotherapy for prostate cancer * Not eligible for a higher priority study at the Karmanos Cancer Institute PATIENT CHARACTERISTICS: Performance status * 0-3 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No organ function restrictions PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy Endocrine therapy * No prior hormonal therapy Radiotherapy * See Disease Characteristics Other * No other concurrent micronutrient supplements, herbs, or vitamins except 1 daily multivitamin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxidative DNA damage at 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life as measured by questionnaire at 3 and 6 months | — |
| Toxicity as measured by number and grade of adverse events weekly during radiation and at 3 and 6 months | — |
| Response as measured by prostate-specific antigen and clinical assessment at 3 and 6 months | — |
| Isoflavone serum level at 3 and 6 months | — |
Countries
United States
Outcome results
None listed