NCT02107430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 Patients With Localized High-risk Prostate Cancer After Primary Radiotherapy
SOTIO a.s.6 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2012年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- Number of Prostate Specific Antigen (PSA) failures in 5 years
研究概览
简要总结
The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA progression times within 5 years for patients with high risk localized Prostate Cancer.
详细描述
Treatment post radical primary prostatectomy Treatment post standard radiotherapy
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 localized prostate cancer of high risk or very high risk fulfilling at least one of the following: T3-T4 stage or Gleason Score 8-10 or PSA level above 20 ng/ml
- •Indication for prostate cancer radical radiotherapy
- •Neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using Luteinizing-hormone-releasing hormone (LHRH) analogues ongoing for at least two months and not longer than 12 months prior randomization
- •Eastern Cooperative Oncology Group (ECOG) 0-2
排除标准
- •Primary surgical treatment of prostate cancer
- •Prior or ongoing chemotherapy for prostate cancer
- •Participation in other clinical study or administration of other evaluated drug within 30 day prior screening
- •Unresolved lasting obstruction of urinary system
- •Other uncontrolled inter-current illness
- •Treatment with immunotherapy against Prostate Cancer
- •Clinically significant cardiovascular disease
- •History of primary immunodeficiency
- •Active autoimmune disease requiring treatment
研究组 & 干预措施
DCVAC/PCa arm post radiotherapy
Experimental
Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy
干预措施: Dendritic Cells DCVAC/PCa (Biological)
Standard radiotherapy
Active Comparator
Standard care
干预措施: Dendritic Cells DCVAC/PCa (Biological)
Standard radiotherapy
Active Comparator
Standard care
干预措施: Standard radiotherapy (Radiation)
结局指标
主要结局
Number of Prostate Specific Antigen (PSA) failures in 5 years
时间窗: Enrollment up to 260 weeks
PSA failure per Phoenix criteria of increase of 2ng/mL over nadir
次要结局
- Proportion of Patients without use of salvage therapy within 5 years(Enrollment up to 260 weeks)
- Frequency of Adverse Events(enrollment up to 260 weeks)
- Proportion of Patients without Objective disease progression within 5 years(Enrollment up to 260 weeks)
研究者
研究点 (6)
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