Phase II Randomized Study of Soy Isoflavones in Patients With Localized Prostate Cancer Treated With Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Oxidative DNA damage at 3 and 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No organ function restrictions
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •No prior hormonal therapy
- •Radiotherapy
- •See Disease Characteristics
- •No other concurrent micronutrient supplements, herbs, or vitamins except 1 daily multivitamin
排除标准
- 未提供
结局指标
主要结局
Oxidative DNA damage at 3 and 6 months
次要结局
- 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