Fulvestrant in Hormone-refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PSA Reduction ≥ 50%
研究概览
简要总结
The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).
详细描述
The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Must give signed written informed consent
- •Must be of age 18 years or older
- •Histologically confirmed adenocarcinoma of the prostate
- •Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy
- •Must have had rise in PSA despite anti-androgen withdrawal
- •Must exhibit two consecutive rises in PSA after the last hormonal manipulation
- •Minimum PSA > 5mg/dL
- •KPS > 80%
- •Up to one prior chemotherapy treatments allowed
- •Life expectancy of greater than 6 months
排除标准
- •Concomitant hormonal therapy other than an LHRH
- •Noncompliance
- •Platelets less than 100 x 10e9 /L
- •International normalization ratio (INR) greater than 1.6
- •Total bilirubin greater than 1.5 x ULRR
- •ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases
- •History of bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency)
- •History of long-term anticoagulant therapy (other than antiplatelet therapy)
- •History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol)
研究组 & 干预措施
Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
PSA Reduction ≥ 50%
时间窗: 3 months
Number of subjects with serum PSA reduction ≥ 50% at 3 months
次要结局
- Stable Disease After One Year(12 months)
- PSA Doubling Time(3 months)
研究者
Sandy Srinivas
Associate Professor of Medicine
Stanford University