A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Decrease in prostate-specific antigen-positive cells
研究概览
简要总结
RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.
详细描述
OBJECTIVES:
- Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy.
- Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
OUTLINE: Patients receive 1 of 2 treatment regimens.
- Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).
- Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
Quality of life is assessed at baseline and at 1 and 3 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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:
- •Diagnosis of localized prostate cancer
- •Diagnosed within the past 6 months
- •T1 or T2 disease
- •Gleason score 5-8
- •Prostate-specific antigen no greater than 20 ng/mL
- •Radical prostatectomy planned
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 2 years
- •Hematopoietic
- •Hemoglobin greater than 9.0 g/dL
- •Platelet count greater than 100,000/mm^3
- •Absolute neutrophil count greater than 1,000/mm^3
- •SGPT and SGOT less than 3 times normal
- •Bilirubin less than 3 mg/dL (less than 1.5 times normal) (patients with an elevated bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)
- •Creatinine less than 2.0 mg/dL
- •Cardiovascular
- •No venous thrombosis within the past year
- •Patients must use effective barrier contraception
- •No other medical condition that would preclude study therapy
- •No known soy intolerance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •No concurrent hormonal therapy for prostate cancer
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
- •No concurrent soy supplements
- •No concurrent foods high in genistein
- •No concurrent active therapy for neoplastic disorders
排除标准
- 未提供
研究组 & 干预措施
Group B
Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
干预措施: genistein (Dietary Supplement)
Group A
Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).
干预措施: conventional surgery (Procedure)
Group B
Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
干预措施: conventional surgery (Procedure)
Group A
Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).
干预措施: genistein (Dietary Supplement)
结局指标
主要结局
Decrease in prostate-specific antigen-positive cells
时间窗: At time of surgery
Alteration in cell morphology
时间窗: At time of surgery
Toxicity
时间窗: At surgery & monthly thereafter during treatment (3 mos)
次要结局
未报告次要终点