Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Oxidative DNA damage as measured by 5-hydroxymethyluridine level
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the development of early cancer. Soy isoflavones may be effective in delaying the development of early prostate cancer.
PURPOSE: This randomized phase II trial is studying different regimens of soy isoflavones to compare how well they work in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer (adenocarcinoma).
详细描述
OBJECTIVES:
- Compare blood/prostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy isoflavones before radical prostatectomy.
- Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated with these regimens.
- Determine the potential response, in terms of tumor and prostatic intraepithelial neoplasia grade and volume, extraprostatic extension, and serum prostate-specific antigen level, in patients treated with soy isoflavones and in those treated with placebo.
- Determine the safety of soy isoflavone supplementation in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study. Patients are stratified according to tumor stage (T1c vs T2). Patients are randomized to 1 of 4 treatment arms.
- Arm I (control group): Patients receive oral placebo once daily.
- Arm II: Patients receive oral soy isoflavones and oral placebo once daily.
- Arm III: Patients receive a higher dose of oral soy isoflavones and oral placebo once daily.
- Arm IV: Patients receive a higher dose (higher than arm III) of oral soy isoflavones once daily.
In all arms, treatment continues for 2-6 weeks (depending on the time from study entry to planned surgery) in the absence of unacceptable toxicity. All patients then undergo radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Stage T1c or T2
- •Disease confined to the prostate gland
- •Planning to undergo radical prostatectomy within the next 3-4 weeks
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •ALT and AST less than 2 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 2 times ULN
- •Not specified
- •Fertile patients must use effective barrier contraception
- •Medically cleared for surgery
- •No concurrent thyroid disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior biological therapy for prostate cancer
- •No concurrent biological agents
- •Chemotherapy
- •No prior chemotherapy for prostate cancer
- •No concurrent chemotherapy
- •Endocrine therapy
- •No prior hormonal therapy for prostate cancer
- •No concurrent thyroid hormone replacement medication
- •No concurrent hormonal therapy
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
- •At least 3 months since prior high-dose nutritional supplements
- •No concurrent regular use (more than once weekly) of soy products greater than 50 g of soy protein or 50 mg of soy isoflavone
- •No concurrent high-dose nutritional supplements
- •Standard-dose single multivitamin tablet (e.g., Centrum™) allowed
- •No concurrent herbs
- •No concurrent soy foods
- •No other concurrent isoflavone supplements
- •No other concurrent antineoplastic agents
排除标准
- 未提供
研究组 & 干预措施
Placebo
Arm I (control group): Patients receive 4 placebo capsules by mouth daily for three weeks.
干预措施: neoadjuvant therapy (Procedure)
Placebo
Arm I (control group): Patients receive 4 placebo capsules by mouth daily for three weeks.
干预措施: Placebo (Other)
Soy isoflavones and placebo
Arm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks.
干预措施: neoadjuvant therapy (Procedure)
Soy Isoflavones/Placebo
Arm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks.
干预措施: neoadjuvant therapy (Procedure)
Soy isoflavones and placebo
Arm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks.
干预措施: Placebo (Other)
Soy Isoflavones/Placebo
Arm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks.
干预措施: Placebo (Other)
Soy Isoflavones
Arm IV: Arm III: Patients receive oral soy isoflavones (PTI G-2535) 600 mg genistein capsules by mouth daily for 3 weeks.
干预措施: soy isoflavones (Dietary Supplement)
Soy Isoflavones/Placebo
Arm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks.
干预措施: soy isoflavones (Dietary Supplement)
Soy isoflavones and placebo
Arm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks.
干预措施: soy isoflavones (Dietary Supplement)
结局指标
主要结局
Oxidative DNA damage as measured by 5-hydroxymethyluridine level
时间窗: at 3 weeks
Lipid oxidation as measured by 8-isoprostane level
时间窗: at 3 weeks
次要结局
- Tumor size, grade, and extension(at 3 weeks)
- Prostate-specific antigen and prostatic intraepithelial neoplasia grade(at 3 weeks)
- Biomarkers of cell growth, differentiation, and apoptosis(at 3 weeks)
- Toxicity as measured by number and grade of adverse events(at 3 weeks)