NCT00068731已完成2 期
A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 18
- 主要终点
- percentage of patients with asymptomatic androgen-independent metastatic prostate cancer and an elevated prostate-specific antigen (PSA) level who sustain a decline in PSA after 4 months of treatment with lycopene
研究概览
简要总结
RATIONALE: Lycopene, a substance found in tomatoes, may lower prostate-specific antigen (PSA) levels and slow or prevent the development of prostate cancer.
PURPOSE: Phase II trial to study the effectiveness of lycopene in treating patients who have asymptomatic metastatic prostate cancer and a rising PSA level.
详细描述
OBJECTIVES:
Primary
- Determine the percentage of patients with asymptomatic androgen-independent metastatic prostate cancer and an elevated prostate-specific antigen (PSA) level who sustain a decline in PSA after 4 months of treatment with lycopene.
Secondary
- Determine the response duration of PSA decline in patients treated with this therapy.
- Determine the time to the first consistent PSA increase in patients treated with this therapy.
- Determine whether a decline in PSA coincides with evidence of disease regression on physical examination or radiographic assessment in patients treated with this therapy.
- Determine the adverse event profile of this therapy in these patients.
- Determine the factors that motivate prostate cancer patients to enroll in a nutritional-based therapy study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 androgen-independent prostate cancer
- •Asymptomatic metastatic disease
- •Unlikely to become symptomatic within the next 4 months
- •No bone pain, shortness of breath, fatigue, or urinary symptoms directly attributable to prostate cancer
- •Radiologic, physically palpable, and/or biochemical evidence of tumor progression after prior orchiectomy OR during treatment with a luteinizing hormone-releasing hormone (LHRH) agonist OR after initiation of another hormonal agent
- •Sustained prostate-specific antigen (PSA) elevation, defined by the following:
- •PSA greater than 5 ng/mL
- •At least 2 consecutive increases in PSA at least 1 week apart
- •Sustained increase in PSA at least 4 weeks after discontinuation of prior flutamide (or other antiandrogen therapy) or megestrol AND at least 6 weeks after discontinuation of prior bicalutamide
- •No known CNS metastases or carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Not specified
- •Bilirubin no greater than 1.5 mg/dL* NOTE: *Includes patients with liver involvement secondary to tumor
- •See Disease Characteristics
- •Creatinine no greater than 2 times upper limit of normal
- •See Disease Characteristics
- •No other malignancy within the past 5 years except basal cell skin cancer
- •No medical or psychiatric condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior immunotherapy
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •More than 4 weeks since prior hormonal therapy (other than an LHRH agonist)
- •No concurrent corticosteroids
- •No concurrent progestational agents
- •No concurrent new hormonal therapy
- •Radiotherapy
- •No concurrent radiotherapy, including radiotherapy for new bone disease
- •See Disease Characteristics
- •More than 4 weeks since other prior anticancer therapy
- •No other concurrent investigational anticancer agents
- •No other concurrent alternative medicine therapies (e.g., saw palmetto or PC-SPES)
排除标准
- 未提供
研究组 & 干预措施
lycopene
Experimental
Patients receive oral lycopene twice daily on days 1-28. Courses repeat every 28 days for at least 4 months in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
干预措施: lycopene (Dietary Supplement)
结局指标
主要结局
percentage of patients with asymptomatic androgen-independent metastatic prostate cancer and an elevated prostate-specific antigen (PSA) level who sustain a decline in PSA after 4 months of treatment with lycopene
时间窗: Up to 4 months
次要结局
- disease regression(Up to 5 years)
- time to the first consistent PSA increase(Up to 5 years)
- response duration(Up to 5 years)
研究者
研究点 (18)
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