NCT01133704已完成3 期
A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Dendreon0 个研究点目标入组 98 人开始时间: 2000年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 主要终点
- Overall Time to Disease Progression
研究概览
简要总结
This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 documented adenocarcinoma of the prostate
- •Metastatic disease as evidenced by soft tissue and/or bony metastases
- •Prostate-specific antigen value of at least 5 ng/mL
- •Tumor progression while on hormonal therapy
- •Castration levels of testosterone (defined as less than 50 ng/dL)
- •Life expectancy of at least 16 weeks
- •Adequate hematologic, renal, and liver function
排除标准
- •Visceral organ metastases
- •Metastatic disease expected to be in need of radiation therapy within 4 months.
- •Concurrent therapy with experimental agents
研究组 & 干预措施
sipuleucel-T (APC8015)
Active Comparator
干预措施: sipuleucel-T (Biological)
Placebo
Placebo Comparator
干预措施: APC-Placebo (Biological)
结局指标
主要结局
Overall Time to Disease Progression
时间窗: from randomization to 36 months
Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.
次要结局
- Overall Survival(Time from randomization until 36 months)
研究者
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