NCT01220817已完成2 期
Safety and Efficacy of POMx in Men With Prostate Cancer: An 18-Month, Randomized, Double-Blind, Dose-Finding Study of the Effects of Two (2) Doses of Pomegranate Juice Extract Capsules (1 or 3 Capsules/Day) on Rising Prostate Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Prostate specific antigen doubling time (PSADT)
研究概览
简要总结
When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is effective in slowing the rise of PSA as measured by PSA doubling time in men following initial therapy for prostate cancer. Further, the investigators believe that POMx will be shown to be safe and well tolerated.
详细描述
The study will be an 18-month, prospective, multi-center, double-blind, dose finding study with subjects who have undergone definitive treatment (surgery, cryotherapy, radiation therapy or brachytherapy) for primary prostate tumor and have had documented rising PSA on a minimum of 3 time points each at least 1 month apart, higher than the reference value noted within 1 year of study entry.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject has histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Subject has undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor.
- •Subject with a rising PSA post-prostatectomy may consider radiation as an alternative. If subject declines radiation, he may be considered eligible in this setting.
- •Subject has a rising PSA on a minimum of 3 time points each at least 1 month apart, higher than the reference value noted within 1 year of study entry and defined as:
- •Absolute level of PSA >0.4 ng/mL following surgery.
- •Absolute level of PSA >1.5 ng/mL following radiation or cryotherapy.
- •Absolute level of PSA >0.4 ng/mL for subjects treated with multiple treatment modalities (e.g., surgery + radiation, radiation + cryotherapy, etc.).
- •Absolute level of PSA > nadir + 2 following neoadjuvant hormonal therapy along with external beam radiation.
- •Interim PSA values during the immediate pre-study interval may demonstrate a "fluctuation" including a decline; however, the study baseline PSA must have shown a rise within the pre-study 1 year period.
- •Study baseline PSAs must be determined within 4 weeks of study entry.
- •First postoperative PSA permitted if detectable.
- •Subject is >18 years or age.
- •Subject has life expectancy of greater than 6 months.
- •Subject has ECOG performance status 0, 1 or 2
- •Subject has testosterone level of >150 ng/mL at screening.
- •Subjects has normal organ and marrow function as defined below:
- •leukocytes >3,000/mcL
- •absolute neutrophil count >1,500/mcL
- •platelets >100,000/mcL
- •total bilirubin within normal limits except for Gilberts
- •AST(SGOT)/ALT(SGPT) >2.5 X upper limit of normal
- •creatinine > 2.5 upper limit of normal
- •testosterone level >150 ng/mL
- •Subject agrees to abstain from other commercially available pomegranate 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 while participating in the study.
- •Subject has signed a written informed consent document and agrees to comply with requirements of the study.
排除标准
- •Subject has known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology.
- •Subject has received any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, herbal therapies containing estrogen) for a minimum of 1 year prior to study.
- •Subject has had 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.
- •Subject has consumed more than two 8 ounce glasses of pomegranate juice per week over the past 2 months.
- •Subject has a known allergy to pomegranate juice or ellagic acid.
- •Subject has 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.
研究组 & 干预措施
1 POMx capsule
Active Comparator
1 POMx capsule daily
干预措施: 1 POMx capsule (Drug)
3 POMx capsules daily
Experimental
干预措施: 3 POMx capsules (Drug)
结局指标
主要结局
Prostate specific antigen doubling time (PSADT)
时间窗: PSADT assessed at baseline
All subjects who have a baseline PSA value and at least 1 on study PSA value. The PSADT will be calculated as ln 2 (0.693)/ β (slope of the linear regression fit to ln PSA vs. time in months).
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Safety and tolerability will be continuously assessed throughout the trial)
- Objective PSA response(PSA levels will be assessed every 3 months throughout the trial)
研究者
研究点 (1)
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