Phase I/II Study of Safety and Efficacy of Muscadine Plus (MPX) in Men With Prostate Cancer: a Randomized,Double-blind,Placebo Controlled Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 8
- 主要终点
- (Phase II) Prostate Specific Antigen Doubling Time (PSADT)
研究概览
简要总结
This research is being done to test an investigational product called Muscadine Plus in the treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific antigens (PSA) level.
详细描述
In phase I the investigators are evaluating the safety of the product and checking blood levels of the active components. In phase II the investigators are evaluating the effect of MPX on PSA doubling time
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)
盲法说明
Phase 1 (Arms 1) - open label Phase 2 (Arms 2-4) - randomized, double-blind
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
- •Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor.
- •Rising PSA on a minimum of 3 time points (including screening psa) within the 12 months prior to study initiation.
- •> 18 years of age.
- •Life expectancy of greater than 6 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or
- •Testosterone level of ≥1.5 ng/mL at screening.
- •Adequate kidney, liver and bone marrow function
- •Agrees to abstain from other commercially available MP products while participating in this study.
- •Subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc) has been stable for at least 2 months prior to screening and the subject agrees not to stop or change the dose(s) while participating in the study.
- •Signed a written informed consent document and agrees to comply with requirements of the study.
排除标准
- •Known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 2.0 cm maybe considered nonspecific and the patient would be eligible
- •Receipt of any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 6 months prior to study
- •Prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product
- •Consumption of Muscadine Plus over the past 2 months
- •Known allergy to muscadine grapes or ellagic acid
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Negative PSA doubling time (1 time point may be excluded per 3e inclusion criteria)
研究组 & 干预措施
Phase 1: Dose-escalation of Muscadine Plus Grape Skin Extract
Muscadine Plus Grape Skin Extract (MPX): Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
干预措施: Muscadine Plus Grape Skin Extract (Drug)
Phase 2: Placebo control
Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
干预措施: Placebo oral capsule (Drug)
Phase 2: Low-dose MPX
Randomly-assigned participants receive low-dose (500mg) MPX
干预措施: Low-dose MPX (Drug)
Phase 2: High-dose MPX
Randomly-assigned participants receive high-dose (4000mg) MPX
干预措施: High-dose MPX (Drug)
结局指标
主要结局
(Phase II) Prostate Specific Antigen Doubling Time (PSADT)
时间窗: Change from baseline to month 12
To define the effects of placebo and two different daily doses of MPX on PSADT in men who have rising PSA after initial definitive therapy for localized prostate cancer.
(Phase I) Maximum Tolerated Dose
时间窗: Up to 7 months post-intervention
To determine the recommended dosing for Muscadine Plus and to evaluate the safety and tolerability of Muscadine Plus in prostate cancer patients with rising PSA following definitive therapy.
次要结局
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability(At month 12 post-intervention)
- (Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline(At month 12 post-intervention)
- (Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%(At month 12 post-intervention)