A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 5
- 主要终点
- Occurrences of Treatment Effect on Biomarkers in Each Group
研究概览
简要总结
RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.
详细描述
OBJECTIVES:
- Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients with localized prostate cancer.
- Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients.
- Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients.
- Compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients.
- Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial neoplasia. Patients are randomized to 1 of 7 treatment groups.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed localized prostate cancer
- •Stage I or II
- •Scheduled prostatectomy between 4-6 weeks after initial biopsy
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •No known history of hepatic disease
- •No known history of renal disease
- •No known history of thyroid disease
- •Body mass index no greater than 32
- •Omnivorous diet
- •No known allergy to study supplements
- •No evidence of prostatitis or urinary tract infection
- •No other prior malignancy except nonmelanoma skin cancer
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent thyroid hormone replacement medications
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •At least 30 days since prior antibiotics
- •At least 30 days since prior diet high in soy and/or lycopene products (e.g., greater than 40 mg soy/day and/or greater than 15 mg lycopene/day)
- •No other concurrent nutritional supplements, including modular supplements with other carotenoids and isoflavones
- •No prior or concurrent therapy for prostate cancer
排除标准
- 未提供
研究组 & 干预措施
Oral isoflavones with multivitamin
Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
干预措施: Multivitamin (Dietary Supplement)
Oral lycopene with multivitamin
Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
干预措施: Multivitamin (Dietary Supplement)
Multiple vitamin alone
Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
干预措施: Multivitamin (Dietary Supplement)
Oral lycopene with multivitamin
Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
干预措施: Lycopene (Dietary Supplement)
Oral isoflavones with multivitamin
Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
干预措施: Soy isoflavones (Dietary Supplement)
结局指标
主要结局
Occurrences of Treatment Effect on Biomarkers in Each Group
时间窗: 4 years
Effect of isoflavones and lycopene on endpoint biomarkers as measured by tissue cell proliferation, apoptosis, or programmed cell death at prostate cancer biopsy and surgical excision
次要结局
- Occurrences of Plasma Level Changes for Each Group(4 years)
- Occurrence of Tissue Level Increases(4 years)
- Occurrences of Disease Progression for Each Group(4 years)
- Occurrences of Hormonal Effect(4 years)