Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to reach peak serum concentration
研究概览
简要总结
A proof of concept clinical trial to assess the synergism of curcumin (CURC) and ursolic acid (UA). Before further testing within formal cancer clinical trials, we must (1) evaluate the bioavailability and safety, (2) confirm the presence of metabolites in the target organ, and (3) validate the appropriate mechanism of effect
详细描述
Once a subject is identified that may meet eligibility criteria, the physician and/or study investigators will be alerted to the potential candidate and will introduce the study to the patient at their standard of care (SOC) appointment or via telephone. Patients will be given the option for enrollment and if they agree, informed consent will be discussed and obtained provided they meet all inclusion/exclusion criteria. Following informed consent, subjects will be assigned to one of the following cohorts:
Cohort 1:
• Ursolic Acid (150 mg) BID (twice a day)
Cohort 2:
• Curcumin (600 mg) BID
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 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
- •Have proven diagnosis of prostate cancer with Gleason Group 3 or lower and planning to undergo radical prostatectomy
- •Be able to give informed consent
- •Be age 18 or older
- •Able to stop supplements
排除标准
- •Unable to give informed consent
- •Age < 18
- •High-risk prostate cancer or suspected metastasis
- •Unable to swallow pills
- •Unable to stop supplements
研究组 & 干预措施
Ursolic Acid
Administration of Ursolic Acid to subjects who are scheduled to undergo radical prostatectomy
干预措施: Ursolic Acid (Drug)
Curcumin
Administration of Curcumin to subjects who are scheduled to undergo radical prostatectomy
干预措施: Curcumin (Drug)
Ursolic Acid and Curcumin
Administration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy
干预措施: Ursolic Acid (Drug)
Ursolic Acid and Curcumin
Administration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy
干预措施: Curcumin (Drug)
结局指标
主要结局
Time to reach peak serum concentration
时间窗: Baseline to 8 weeks
The pharmacokinetic parameter, the area under the curve (Tmax) representing the time it takes to reach Cmax of ursolic acid, curcumin, and their metabolites will be graphed.
Number, frequency, duration, and relation of toxicity events
时间窗: Baseline to 8 weeks
Safety will be compared to evaluate the number, frequency, duration, and relation of toxicity events to CURC/UA combination, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03.
Half-life
时间窗: Baseline to 8 weeks
The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.
Peak serum concentration
时间窗: Baseline to 8 weeks
Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.
次要结局
- Levels of UA, CURC, and metabolites in prostate tissue(Baseline to 8 weeks)
- Immunohistochemistry measurement(Baseline to 8 weeks)