NCT02107391已完成2 期
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Combination With Hormone Therapy in Patients With Metastatic Prostate Cancer
SOTIO a.s.0 个研究点目标入组 63 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 主要终点
- Proportion of patients with PSA Progression
研究概览
简要总结
The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.
详细描述
Use of vaccine to improve Prostate Specific Antigen (PSA) levels.
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
- 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
- •Male 18 years and older
- •Histologically confirmed prostate adenocarcinoma
- •Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy)
- •Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization
- •Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL)
- •Eastern Cooperative Oncology Group (ECOG) 0-2
排除标准
- •Confirmed brain and/or leptomeningeal metastases
- •Prior or ongoing chemotherapy for prostate cancer
- •Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
- •Other uncontrolled intercurrent illness
- •Treatment with immunotherapy against prostate cancer
- •Clinically significant cardiovascular disease
- •Active autoimmune disease requiring treatment
研究组 & 干预措施
DCVAC/PCA added Standard Hormone Therapy
Experimental
Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy
干预措施: Dendritic Cells DCVAC/PCa (Biological)
Standard of Care Hormone Therapy
Active Comparator
Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate
干预措施: Leuprolide acetate (Drug)
Standard of Care Hormone Therapy
Active Comparator
Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate
干预措施: Goserelin Acetate (Drug)
结局指标
主要结局
Proportion of patients with PSA Progression
时间窗: 104 weeks
次要结局
- Proportion of patients with Progression of Disease(0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks)
- Frequency of Adverse Events(0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks)
- Frequency of Skeletal Related Events(0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks)
- Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30(0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks)
- Changes in Pain assessed by EORTC QLQ-C30(0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks)
研究者
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