NCT01313273终止3 期
Randomised, Phase III Multicenter, Open Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients Presenting Elevated Chromogranin A Levels
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
The aim of the study is to compare in an exploratory fashion the efficacy on progression-free survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non metastatic castrate resistant prostate cancer patients.
详细描述
LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues
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
- •Histologically proven diagnosis of prostate cancer
- •Evidence of PSA progression despite castrate levels of testosterone (<50 ng/dL) following orchiectomy or during therapy with luteinizing hormone releasing hormone agonists (LHRH-a)
- •Patients with non-metastatic or stable metastatic disease
- •Chromogranin A elevation above normal range (confirmed by a second evaluation at least 1 week later) [cut off levels will be > 20 U/L for enzyme linked immunosorbent (ELISA) assay and > 100 ng/ml for immunoradiometric (IRMA) assay]
排除标准
- •Patients who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel)
- •First line treatment with antiandrogen in monotherapy
- •Visceral metastasis
- •Previous or concomitant treatment with a somatostatin analogue
研究组 & 干预措施
Arm A
Other
干预措施: Non steroidal anti androgens and LHRH-a (Drug)
Arm B
Experimental
干预措施: Lanreotide, non steroidal anti androgens and LHRH-a (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Week 96
次要结局
- Prostate Specific Antigen (PSA) Response(Week 96)
- Median Time to PSA Response(Week 96)
- Reduction in Chromogranin A Serum Levels(Baseline, Week 96)
研究者
研究点 (1)
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