Phase II Placebo Controlled Trial of Preoperative Lycopene Supplementation in Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Concentration of Lycopene in Prostatic Surgical Tissue
研究概览
简要总结
This randomized phase II trial studies how well different doses of lycopene work in treating patients undergoing radical prostatectomy for prostate cancer. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from growing or coming back after surgery.
详细描述
PRIMARY OBJECTIVES:
I. Compare the differences in tissue concentrations of lycopene in patients with prostate cancer undergoing radical prostatectomy treated with different doses of neoadjuvant lycopene supplementation.
II. Compare the change in serum lycopene concentration from baseline and at 4-7 weeks in patients treated with different doses of lycopene.
SECONDARY OBJECTIVES:
I. Determine the effect of this treatment in down-regulating 5-alpha-reductase activity by measuring the change in the ratio of testosterone (T) to dihydrotestosterone (DHT) in serum at baseline and at 4-7 weeks and the ratio of T:DHT in prostatic surgical tissue post-treatment.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I (placebo)
Patients receive placebo PO QD for 4-7 weeks, and then undergo radical prostatectomy.
干预措施: placebo (Other)
Arm I (placebo)
Patients receive placebo PO QD for 4-7 weeks, and then undergo radical prostatectomy.
干预措施: therapeutic conventional surgery (Procedure)
Arm I (placebo)
Patients receive placebo PO QD for 4-7 weeks, and then undergo radical prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm II (low-dose lycopene)
Patients receive low-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
干预措施: therapeutic conventional surgery (Procedure)
Arm II (low-dose lycopene)
Patients receive low-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm II (low-dose lycopene)
Patients receive low-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
干预措施: lycopene (Drug)
Arm III (high-dose lycopene)
Patients receive high-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
干预措施: therapeutic conventional surgery (Procedure)
Arm III (high-dose lycopene)
Patients receive high-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
干预措施: laboratory biomarker analysis (Other)
Arm III (high-dose lycopene)
Patients receive high-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
干预措施: lycopene (Drug)
结局指标
主要结局
Concentration of Lycopene in Prostatic Surgical Tissue
时间窗: At 4-7 weeks
Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.
Serum Levels (ug/dL) of Total Lycopene at Baseline and During Treatment by Group
时间窗: Baseline and weeks 4 and 7
Serum levels (ug/dL) of total lycopene at baseline and during treatment by group were measured.
次要结局
- Ratio of T:DHT in Prostatic Surgical Tissue(At 4-7 weeks)
- Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2(Baseline and at 4-7 weeks)
- Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue(At 4-7 weeks)
- Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3(At baseline and at 4-7 weeks)
- Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay(At baseline and at 4-7 weeks)
- Expression of GST-pi in Prostatic Surgical Tissue(At 4-7 weeks)
- Histological Characteristics of Prostatic Surgical Tissue(At 4-7 weeks)
- Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue(At 4-7 weeks)
- Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum(Baseline and at 4-7 weeks)