NCT01483586终止2 期
Efficacy and Safety of Oral Kanglaite (KLTc)in Men With Prostate Cancer: Randomized, Dose-Ranging Study of the Effects of KLTc on Prostate Specific Antigen (PSA) Doubling Time Among Men With Rising PSA Levels After Definitive Local Therapy
KangLaiTe USA5 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- prostate specific antigen doubling time (PSADT)
研究概览
简要总结
This research is being done to evaluate the safety and efficacy of the investigational Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.
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
- None
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
- •confirmed adenocarcinoma of the prostate
- •undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor with a rising PSA
- •life expectancy greater than 6 months
- •has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- •use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc.) has been stable for at least 2 months prior to screening and the patient agrees not to stop or change the dose while participating in the study.
- •Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper institutional limits of normal, ALT and AST ≤ 2.5 times the upper institutional limits of normal
- •Adequate renal function with serum creatinine ≤ 1.5 times the upper institutional limits of normal
- •Adequate hematologic function (absolute neutrophil counts ≥ 1,500 mm3 and platelets ≥ 100,000 mm3)
- •All electrolytes (including potassium, sodium, and serum or ionized calcium) must be within normal limits
排除标准
- •Patients with evidence of metastatic disease would be excluded, except for presence of positive lymph nodes from the surgical pathology. Similarly, patients with radiological evidence of lymph nodes < 2 cm that lack pathological confirmation would be eligible
- •Patients with a PSA doubling time of <6months at screening would be excluded
- •Patients meeting Phoenix criteria for biochemical failure (nadir + ≥2ng/mL increase in serum PSA) who wish additional conventional therapy
- •Any concurrent malignancy other than adequately treated basal or squamous cell skin cancer or superficial bladder cancer
- •Any psychiatric or other disorders such as dementia that would prohibit the patient from understanding or rendering informed consent or from fully complying with protocol treatment and follow-up
- •Inability to swallow capsules
- •Patients with a known history of gastrointestinal disease, surgery or malabsorption that could potentially impact the absorption of the study drug
- •Patients requiring the use of a feeding tube
- •Receipt of prior chemotherapy
研究组 & 干预措施
KLTc high dose
Experimental
6 KLTc gelcaps taken four times a day
干预措施: Kanglaite gelcap (Drug)
KLTc low dose
Experimental
3 KLTc gelcaps taken four times a day
干预措施: Kanglaite gelcap (Drug)
结局指标
主要结局
prostate specific antigen doubling time (PSADT)
时间窗: over 12 months on study drug
PSADT is defined as the natural log of 2 (0.693)divided by the slope (beta- rate of change) of the relationship between the log of PSA and the time of PSA measurement using linear regression model
次要结局
- PSA objective response(over 12 months on study drug)
- KLTc intake compliance(each month, up to 12 months on study drug)
研究者
研究点 (5)
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