A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/Pomx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Change in Plasma IGF-1 From Baseline to Post-Treatment
研究概览
简要总结
This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in patients with prostate cancer that is limited to a certain part of the body (localized), who have chosen observation as their treatment plan. The use of pomegranate-extract pill may slow disease progression in patients with localized prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effect of pomegranate fruit extract (PFE) 1000 mg, taken daily for 1 year, on the plasma levels of insulin-like growth factor (IGF-1) from baseline to end of study (52 weeks) in participants undergoing active surveillance (AS) for early stage prostate cancer.
SECONDARY OBJECTIVES:
I. To assess compliance with a once daily oral administration of PFE versus placebo over a 52-week period of time.
II. To assess the toxicity of PFE vs. placebo when taken daily for 52 weeks (+/- 1 week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants must have had a standard-of-care biopsy within 13 months of the baseline study visit and must have been diagnosed with low-grade, clinically localized prostate cancer (Gleason score =< 3+3 with a PSA at baseline < 10 ng/ml in participants < 70 years of age, OR Gleason score =< 3+4 with a PSA at baseline =< 15 ng/ml in participants >= 70 years of age); eligible participants will be those men who are able and willing to undergo AS with PSA monitoring and a scheduled biopsy performed at the end of the study
- •No concurrent treatment (hormonal, radiation or systemic chemotherapy) for prostate cancer during study enrollment is planned (unless participants demonstrate clinical evidence of prostate cancer progression such as symptoms, physical exam findings, a rapidly increasing PSA, or radiologic findings which confirm disease progression)
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 1
- •White blood cells (WBC) >= 3000/mm^3
- •Platelets >= 100,000 mm^3
- •Hemoglobin >= 10 g/dL
- •Total bilirubin =< 1.5 x upper limit of institutional normal
- •Alkaline phosphatase =< 1.5 x upper limit of institutional normal
- •Aspartate aminotransferase (AST) =< 1.5 x upper limit of institutional normal
- •Alanine aminotransferase (ALT) =< 1.5 x upper limit of institutional normal
- •Serum creatinine within 1.5 x upper limit of institutional normal
- •Sodium 135-144 mmol/L (inclusive)
- •Potassium 3.2-4.8 mmol/L (inclusive)
- •Participants will be required to use a medically-approved method of birth control or abstinence if their sexual partner is of child-bearing potential
- •Participants must be willing to forego foods, beverages and supplements containing pomegranate for the duration of the study
- •Ability to understand, and the willingness to sign, a written informed consent document
排除标准
- •Any prior surgery to the prostate within 30 days of baseline procedures; NOTE: Biopsies are not considered surgeries
- •Evidence of other cancer(s) (excluding non-melanoma skin cancer) within last 5 years
- •Prior pelvic radiation for any reason
- •Participants cannot be taking 5-alpha-reductase inhibitors while on study or within 6 months of the baseline study visit
- •Participants may not be taking carbamazepine (tegretol)
- •Participants may not be receiving any other investigational agents
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to PFE
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- •Any significant cardiac event(s) within the 12 months prior to registration, such as episode(s) of symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris or persistent, stable angina pectoris, or cardiac arrhythmia requiring medication
研究组 & 干预措施
Group I (pomegranate-extract pill)
Patients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).
干预措施: Laboratory Biomarker Analysis (Other)
Group I (pomegranate-extract pill)
Patients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).
干预措施: Pharmacological Study (Other)
Group I (pomegranate-extract pill)
Patients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).
干预措施: Pomegranate-Extract Pill (Drug)
Group II (placebo)
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
干预措施: Laboratory Biomarker Analysis (Other)
Group II (placebo)
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
干预措施: Pharmacological Study (Other)
Group II (placebo)
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
干预措施: Placebo (Other)
结局指标
主要结局
Change in Plasma IGF-1 From Baseline to Post-Treatment
时间窗: Baseline to 12 months
The primary endpoint for modulation of intermediate endpoint biomarkers will be the change in the plasma levels of IGF-1 by a quantitative assay (ELISA) from pre-study to post-treatment. The difference between these time points for the placebo group and the pomegranate fruit extract (PFE) group will be tested using a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test.
次要结局
- Compliance: Number of Participants Who Took Study Drug Per Protocol(Up to 1 year)
- Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)(Up to 1 year)
- Change in Plasma Biomarker Levels From Baseline: IGFBP-3(Week 13, Week 26, Week 39, Week 52)
- Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3(Week 13, Week 26, Week 39, Week 52)
- Change in Total Serum Prostate Specific Antigen (PSA) From Baseline(Up to 1 year)
- Change in Serum Testosterone(up to 1 year)
- Prostate Specific Antigen Doubling Time (PSA DT)(up to 52 Weeks)
- Change in Tissue Biomarker Levels: PSA(Baseline to Week 52)
- Change in Tissue Biomarker Levels: IGF-1(Baseline to Week 52)
- Change in Tissue Biomarker Levels: CASP3(Baseline to Week 52)
- Change in Tissue Biomarker Levels: Ki-67(Baseline to Week 52)
- Change in Tissue Biomarker Levels: IGF-Rb(Baseline to Week 52)
- Change in Tissue Biomarker Levels: IGFBP-3(Baseline to Week 52)
- Change in Tissue Biomarker Levels: 8OHdG(Baseline to Week 52)
- Change in Tissue Biomarker Levels: AR(Baseline to Week 52)
- Change in Levels of Pomegranate Fruit Extract (PFE) Constituents/Metabolites: Urolithin A(Change from Baseline at Week 13, Week 26, Week 39, and Week 52)
- Change in Levels of PFE Constituents/Metabolites: Urolithin B(Change from Baseline at Week 13, Week 26, Week 39, and Week 52)
- Change in Gleason Score(Baseline to 1 year)
- Change in Biopsy Tumor Involvement on Prostate Biopsy(Baseline to 1 year)