NCT02064673招募中3 期
Randomized Trial of Adjuvant Curcumin After Prostatectomy
yair lotan1 个研究点 分布在 1 个国家目标入组 608 人开始时间: 2014年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 608
- 试验地点
- 1
- 主要终点
- Serum prostate specific antigen
研究概览
简要总结
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival.
详细描述
This is a prospective study to determine if the adjuvant use of Curcumin improves recurrence-free survival in patients after radical prostatectomy compared to placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Status post radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
- •pathologically confirmed T1-T3 disease
- •no sign of lymph node or metastatic disease
- •pT1-pT3pNxMx patients in whom standard NCCN or AUA guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease. This includes patients with Gleason 6 or 7(T2 disease) and PSA less than
- •Eastern Cooperative Oncology Group(ECOG) status 0-2
- •adequate renal and liver function as well as bone marrow reserve (measured serum creatinine <2mg/dl, bilirubin ≤ 1.5 mg/dl, ANC ≥ 1.5 x 10 (3) uL, platelets ≥ 50 x K/uLL, and hemoglobin ≥ 10 g/dL)
- •30-80 y/o at time of diagnosis with a life expectancy of >= 3 yrs
- •focally positive surgical margins are permitted
- •no plan to receive adjuvant hormone or radiation therapy
- •PSA at the time of enrollment must be undetectable
- •life expectancy of 3 years
排除标准
- •must not have exceeded 3 months from time of surgery to enrollment into study
- •T3b or T4 or node positive disease
- •macroscopic residual disease after surgery
- •hormone therapy before surgery
- •history of gallbladder problems or gallstones, or biliary obstruction, unless patient had cholecystectomy
- •radiation therapy as primary treatment after surgery
- •INR value greater than 1.5
- •AST/ALT are equal or greater than 2 times the upper limit of normal
- •antiplatelet or anticoagulant agents- patients taking 81mg of Aspirin will be allowed with close observation
- •history of gastric or duodenal ulcers or untreated hyperacidity syndromes
- •patients who are currently taking curcumin and are unwilling to stop or plan to take curcumin during the study
研究组 & 干预措施
Curcumin
Active Comparator
Curcumin 500 mg orally twice a day
干预措施: Curcumin (Drug)
Curcumin
Active Comparator
Curcumin 500 mg orally twice a day
干预措施: placebo (Drug)
sugar pill
Placebo Comparator
placebo orally twice a day
干预措施: Curcumin (Drug)
sugar pill
Placebo Comparator
placebo orally twice a day
干预措施: placebo (Drug)
结局指标
主要结局
Serum prostate specific antigen
时间窗: 3 years
Recurrence free survival defined as a total serum prostate specific antigen of \<0.2ng/ml.
次要结局
未报告次要终点
研究者
yair lotan
PROFESSOR
University of Texas Southwestern Medical Center
研究点 (1)
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