NCT00841113已完成3 期
Phase III Study of the Comparison of Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer. A One Year Randomised, Open Label, Multi-Centre Phase III Trial.
Speciality European Pharma Limited0 个研究点目标入组 177 人开始时间: 1999年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 主要终点
- Early castration rates
研究概览
简要总结
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.
详细描述
Inclusion Criteria
- Males over 18 with documented advanced or metastatic prostate cancer
Outcome measures
- Comparative castration rates one week after starting therapy
- Degree of testosterone surge in the first month of treatment.
- Maintenance of medical castration during one year of therapy.
- Comparison of the treatments on QTc prolongation
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 prostate cancer and not previously treated with hormones
- •Evidance of advanced disease or metastases
- •Life expentancy of at least 3 months
- •Normal serum testosterone levels
- •Written informed consent
排除标准
- •Previous endocrine or cytoxic theapy for prostate cancer
- •Known tumour complication of prostate cancer which owuld require immediate treatment
- •Another malignancy other than basal cell cancer
- •History of significant drug hypersensitivity to either LHRH agonists or GnRH antagonists.
- •Congenital or acquired coagulation disorders contraindicating intramuscular injections
- •Pagets disease of the bone
- •QTcB > 450 msec at Day - 14
研究组 & 干预措施
1 Abarelix
Experimental
Investigative drug
干预措施: Abarelix (Drug)
2 Goserelin plus bicalutamide
Active Comparator
Standard therapy
干预措施: Goserelin plus Bicalutamide (Drug)
结局指标
主要结局
Early castration rates
时间窗: One week
次要结局
- Maintenance of medical castration(48 weeks)
研究者
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