NCT00415246终止3 期
A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 100
- 试验地点
- 31
- 主要终点
- Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
研究概览
简要总结
To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient
- •Patient must be 18 years old or over
- •Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy
- •Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment
排除标准
- •Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy)
- •Patient who underwent a previous surgical castration
- •Prostate cancer therapy within 2 months of baseline visit
- •Patient with testosterone level below 150 ng/dL at screening
结局指标
主要结局
Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
时间窗: Day 240
次要结局
- Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.(Day 120)
- Time to escape from castration (Texit)(Prior 4 months)
- Duration of castration in days (Tcast) Changes in PSA levels.
- Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.(Day 120 and 240)
- Time to achieve castration in days post treatment (Tlag)(Day 35)
- Tlag and Texit confirmed by two consecutive measurements taken 1 week apart.
研究者
研究点 (31)
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