VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Prostate-specific Antigen (PSA) Response
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Giving bortezomib with hormone therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone therapy works in treating patients with relapsed prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 120 Years（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
Part A: Velcade
Patient will complete Part A (Velcade only). If the patient has a complete response, he will come off study. If the patient has progressive disease, he will start Part B (Velcade + antiandrogen). If the patient has a partial response or stable disease, he will start Part B after at least a 7-day break.
干预措施: Velcade (Drug)
Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist
Patient will start Part B after completing Part A or may be enrolled to part B only.
干预措施: Velcade (Drug)
Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist
Patient will start Part B after completing Part A or may be enrolled to part B only.
干预措施: LH-RH Agonist (Drug)
Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist
Patient will start Part B after completing Part A or may be enrolled to part B only.
干预措施: Androgen Receptor Antagonists (Drug)
结局指标
主要结局
Prostate-specific Antigen (PSA) Response
时间窗: 3 months after the start of treatment
Time to PSA Progression
时间窗: From on study until time of PSA progression for up to two years
PSA progression is defined as a PSA increase of 50% over the nadir CR or CR/PR value on three successive PSA measurements two months apart to a value of \>= 1.0 ng/ml.
次要结局
- Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0(From start of treatment until end of study, up to 6 months)
- Disease-free Interval(3 months after combined treatment)