A Phase III, Parallel Group, Randomized, Open-label, Multi-centre Clinical Trial of Zoledronic Acid in Males Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 522
- 试验地点
- 1
- 主要终点
- Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
研究概览
简要总结
This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment
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
- •prostate cancer
- •at least one bone metastasis
- •receiving or about to receive androgen deprivation therapy (ADT)
排除标准
- •previous ADT failure
- •previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy
- •abnormal renal function
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Early Group
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
干预措施: Zoledronic Acid (Drug)
Delayed group
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline Serum Prostate-specific Antigen (PSA) level.
干预措施: Androgen Deprivation Therapy (ADT) (Drug)
结局指标
主要结局
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
时间窗: 18 months
Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.
次要结局
- Time to Occurrence of Skeletal Related Event or Death(36 Months)
- Skeletal-related Event(SRE)-Free Survival(36 months)
- Overall Survival at 18 Months and 3 Years(month 18, year 3)