Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy : a Randomized, Double Blind, Placebo-controlled Trial

Samsung Medical Center0 个研究点目标入组 107 人开始时间: 2007年8月30日最近更新: 2017年7月7日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Samsung Medical Center
入组人数: 107
主要终点: Duration of treatment interruption with or without curcumin

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This was a placebo-controlled, double-blind, randomized trial designed with the aim of establishing whether curcumin influenced the duration of treatment interruption and rate of prostatic specific antigen(PSA) progression, compared with placebo among men with prostate cancer receiving intermittent androgen deprivation therapy.

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

性别: Male
接受健康志愿者: 否

入选标准

•patients diagnosed with prostate cancer in biopsy
•among patients with biochemical recurrence after treatment(radical prostatectomy, radiation therapy, focal therapy, etc.) for localized prostate cancer or metastatic prostate cancer at the time of diagnosis, who received intermittent androgen deprivation therapy(IAD)
•patients who off-treatment for the first time by receiving androgen deprivation therapy(ADT) for more than 6 months and PSA nadir remained stable for more than 3 months

排除标准

•previous history of IAD
•patient with other serious or ongoing medical or psychiatric disease other than prostate cancer
•hypersensitivity or suspicious of curcumin
•history of taking health supplements containing curcumin for prostate cancer treatment before 6 months of clinical trial participation

结局指标

主要结局

Duration of treatment interruption with or without curcumin

时间窗: up to 42 months

To determine whether the period from the first interruption of the androgen deprivation therapy to the time when androgen deprivation therapy needs to be retreated differ between curcumin group and placebo group

次要结局

Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo(0,1,2,3,4,5,6,12,18,30,42 months)
Mean change in testosterone(ng/ml) from baseline between curcumin group versus(0,1,2,3,4,5,6,12,18,30,42 months)
Adverse events(0,1,2,3,4,5,6,12,18,30,42 months)

研究者

发起方

Samsung Medical Center

申办方类型

Other

责任方

Sponsor

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