NCT00182052已完成3 期
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.
研究概览
简要总结
The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on patients and their prostate cancer. This study is going to look at what effects rosiglitazone has on prostate specific antigen (PSA) levels.
详细描述
- Patients will be randomly assigned to initial treatment with either rosiglitazone or placebo orally twice daily, every day as long as there is no disease progression or serious side effects. Patients will be asked to complete a drug log to keep track of the medication.
- Before treatment begins the following tests will be performed: physical exam; bone scan; blood work (including PSA level test) and a urine sample.
- While on this study the following tests and procedures will be done once a month: review of side effects and routine blood tests (including PSA levels).
- While on this study the following tests and procedures will be done on months 2 and 4: review of side effects; routine blood tests (including PSA levels) and urine tests.
- If the patient's disease progressed the treatment code will be broken and if the patient was on placebo, they will have the option to begin taking rosiglitazone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Histologically confirmed adenocarcinoma of the prostate
- •Biochemical disease progression following local therapy defined as three rises in PSA with each PSA determination at least 4 weeks apart and each PSA value > or = 0.2ng/ml
- •For men treated with radical prostatectomy, PSA > or = 2 ng/ml
- •For men treated with primary radiation therapy or post-prostatectomy radiation therapy, PSA > or = 2 ng/ml and > 150% post-radiation nadir
- •Not an appropriate candidate for salvage radiation therapy or salvage prostatectomy
- •Baseline PSADT < 24 months
- •CALGB performance status of 0,1 or 2
排除标准
- •Metastatic disease
- •Prior hormonal therapy for recurrent prostate cancer
- •Prior chemotherapy for prostate cancer
- •Current treatment with insulin or an oral hypoglycemic
- •History of treatment with thiazolidinediones
- •Radiation therapy within 6 months
- •SGOT > 1.5 x ULN
- •Fasting blood glucose < 60 mg/dl
- •NYHA Class 3 or 4 cardiac status
研究组 & 干预措施
Group 1
Active Comparator
干预措施: Rosiglitazone (Drug)
Group 2
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.
时间窗: 3 years
次要结局
- Evaluate time to PSA progression as a measure of the activity of rosiglitazone.(3 years)
研究者
Matthew R. Smith, MD, PhD
Professor of Medicine
Massachusetts General Hospital
研究点 (2)
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