A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- The primary end point is rate of disease progression.
研究概览
简要总结
This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance.
详细描述
Prostate cancer is the most common cancer in men with an estimated 180,890 new cases and 26,120 deaths from prostate cancer expected in 2016 in the United States. Although the lifetime risk of developing prostate cancer, the risk of death is only about 3%. A major concern regarding the utility of prostate cancer screening is the risk of over diagnosis and subsequent overtreatment. Many patients with small low grade cancers might not benefit from treatment and treatment can result in lower quality of life. A major concern for patients and physicians using active surveillance (AS) is the risk for progression of disease. Several reviews of active surveillance suggest that stage or grade progression occur in approximately 30% of patients with some patients choosing treatment due to anxiety. Overall survival in AS series is uniformly high but the need for close monitoring and anxiety associated with risk of progression has inhibited use among patients.
There are no currently accepted medications to reduce risk of progression in patients with active surveillance. With the rising use of AS, there is a role for therapies to reduce risk for progression in this population. One promising source of therapies involves use of nutraceuticals for the prevention and treatment of human diseases. Curcumin is a widely studied nutraceutical that was first discovered about two centuries ago from the rhizomes of Curcuma longa (turmeric). Curcumin is a safe supplement and in this study we will evaluate if it reduces risk of cancer progression compared to placebo.
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)
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 40-89 years
- •Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)
- •May have had biopsy within last 12 months
- •≤4 separate locations in the prostate involved with cancer. If multiple cores are obtained from same lesion or area than this will count as one location.
- •Gleason score ≤6 with no Gleason pattern 4
- •Clinical stage T1c-T2a/b
- •Serum PSA ≤15 ng/ml
- •Life expectancy > 5 years
排除标准
- •Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostatectomy)
- •Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor
- •Use of anabolic steroids or drugs with antiandrogenic properties
- •Prostate volume >150 cm³
- •Patients who are taking antiplatelet, anticoagulant agents or have a history of a bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with close observation
- •History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on stable doses (2 months of therapy) of GERD medication allowed.
- •Patients who are currently taking Curcumin and are unwilling to stop or plan to take Curcumin during the study
- •Patients with a history of gallbladder problems or gallstones or biliary obstruction, unless patient had cholecystectomy
研究组 & 干预措施
Curcumin
- Other names for the supplement: BCM-95 CG (Biocurcumax),Tumeric
- Manufacture- DolCas Biotech, LLC.
- Classification - type of agent: Supplement
- Protocol dose: 500 mg twice
干预措施: Curcumin (Drug)
Placebo
Drug: placebo
placebo orally twice a day Other Names: •sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
The primary end point is rate of disease progression.
时间窗: 2 years
The primary endpoint is the number of patients who have progressed at 2 years of follow up defined as one of the following events: receipt of primary therapy for prostate cancer (eg, prostatectomy, radiation, hormonal therapy) or pathologic progression (\> 4 cores involved, ≥ 50% of any core involved, or any Gleason score ≥ 7)
次要结局
未报告次要终点
研究者
yair lotan
MD, Professor and Chief of Urologic Oncology
University of Texas Southwestern Medical Center