NCT02107404已完成2 期
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial With Active Cellular Immunotherapy DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy
SOTIO a.s.13 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年4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
- 150
- 试验地点
- 13
- 主要终点
- Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
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 doubling times for patients with localized 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
- 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 pT2 prostate cancer
- •Post radical prostatectomy
- •PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months
- •Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml
- •Eastern Cooperative Oncology Group (ECOG) 0-2
排除标准
- •Confirmed brain and/or leptomeningeal metastases
- •Prior androgen deprivation therapy or orchiectomy 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 Arm
Experimental
Dendritic Cells DCVAC/PCA Experimental therapy
干预措施: Dendritic Cells DCVAC/PCa (Biological)
Standard Therapy
No Intervention
No Intervention
结局指标
主要结局
Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
时间窗: 40 Weeks
次要结局
- Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization(104 Weeks)
- Number of Patients requiring further therapy at 2 years(104 Weeks)
- Proportion of patients with progressive increase in PSA within 2 years of randomization(104 Weeks)
- Overall survival(104 Weeks)
- Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization(104 Weeks)
- Proportion of Patients with Objective disease progression within 2 years(104 Weeks)
- Frequency of Adverse Events(0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks)
- Proportion of patients after RPE with biochemical relapse within 2 years of randomization(104 Weeks)
研究者
研究点 (13)
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