Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 6
- 主要终点
- Percentage of Patients With PSA Response
研究概览
简要总结
Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will evaluate the toxicities and measure quality of life. We will assess PSA response and measurable disease response. This will be a trial available to the Cancer Institute of New Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic evaluations every three weeks. We will assess quality of life through a questionnaire given to patient every three weeks.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Transdermal estradiol
干预措施: Transdermal Estradiol (Drug)
结局指标
主要结局
Percentage of Patients With PSA Response
时间窗: 3 years
PSA Response is a critical outcome measure used to assess the efficacy of treatments for conditions such as prostate cancer. PSA, or Prostate-Specific Antigen. The PSA Response is a measure of the change in PSA levels before and after a specific treatment intervention.
次要结局
- To Measure Quality of Life of Participants Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).(3 years)
- Measurable Disease Response Assessment in Participants With Hormone and Chemotherapy Refractory Prostate Cancer(4 years)
- Time to Progression(3 years)
- Plateau Level of Estradiol and Testosterone Response in Androgen-Resistant Population With 0.4mg/Day Transdermal Estradiol Patch(3 years)