NCT00336934已完成不适用
A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy
Roll International Corporation0 个研究点目标入组 183 人开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 主要终点
- Objective response
研究概览
简要总结
RATIONALE: Pomegranate extract may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after surgery or radiation therapy for localized prostate cancer.
PURPOSE: This randomized trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the effects of pomegranate extract in patients with and rising prostate-specific antigen (PSA) levels after surgery or radiotherapy for localized prostate cancer.
- Determine the effect of a daily oral dose of pomegranate extract on the absolute value of PSA and on the change in PSA doubling time in these patients.
Secondary
- Assess toxicities associated with daily oral dosing of pomegranate extract in these patients.
- Determine the effect of pomegranate extract on positive PSA doubling-time outcome, defined as greater than 150% baseline or a negative post-treatment PSA doubling time (i.e., declining PSA).
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor
- •Documented rising prostate-specific antigen (PSA)
- •Absolute level of PSA > 0.2 ng/mL after surgery
- •Absolute level of PSA > 1.0 ng/mL after radiation or cryotherapy
- •Absolute level of PSA ≥ 0.4 ng/mL after multiple treatment modalities (e.g., surgery with radiotherapy or radiotherapy with cryotherapy)
- •PSA must be ≥ 100% above best nadir achieved
- •PSA doubling time > 3 months or ≤ 24 months
- •Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months
- •The interval between PSA time points must be > 2 weeks
- •PSA ≤ 7.0 ng/mL
- •Patients who underwent radical prostatectomy and never achieved undetectable serum PSA after surgery are not eligible
- •Gleason score ≤ 7
- •No histologically positive lymph nodes
- •No evidence of metastatic disease by physical examination, CT scan, or bone scan
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 6 months
- •ECOG performance status 0 or 1
- •No significant concomitant medical or psychiatric conditions that would limit study compliance
- •No known allergies to pomegranate extract
- •No known diabetes with hemoglobin A_1c level > 7.0% in the past 3 months
- •Diabetic patients entering study who have not had hemoglobin A_1c level measured in the past 3 months must have levels measured at study initiation
- •No clinically abnormal laboratory values > 2 times the upper limit of normal
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 4 weeks since prior and no concurrent experimental drugs, high-dose steroids, or other cancer treatment
- •No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy
- •Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150 ng/dL
- •No prior or concurrent hormonal therapy for rising PSA after primary therapy for prostate cancer
- •No finasteride or dutasteride at any time point after primary therapy and during study therapy
- •No other concurrent commercial pomegranate products
- •No other concurrent systemic or local therapy for prostate cancer
- •Concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed provided dose has been stable for ≥ 2 months prior to study entry and there are no plans to change or stop the supplements during study therapy
排除标准
- 未提供
结局指标
主要结局
Objective response
时间窗: 12 months
次要结局
- Response duration(12 months)
- Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times(12 months)
研究者
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