NCT00378690已完成3 期
A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 706
- 主要终点
- Time to PSA progression
研究概览
简要总结
Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •At study entry (visit 1):
- •Written informed consent
- •Male subjects aged >=18 and <80 years old
- •Locally advanced (stage T3 or T4) prostate cancer or Relapsing prostate cancer following radical prostatectomy or,Relapsing prostate cancer following radiotherapy
- •Gleason score of >=6
- •ECOG performance status of 0-
- •Life expectancy at least 5 years
- •At randomization (visit 4):
- •Two successive decreasing serum PSA levels <=1 ng/ml
排除标准
- •At study entry (visit 1):
- •Any suspected second primary tumors
- •Evidence of metastatic disease
- •Other malignancy within the last 5 years except
- •Acute spinal cord compression, uni- or bilateral ureteric obstruction
- •Any concurrent biological response modifier therapy
- •Concurrent chemotherapy
- •Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy
- •Less than 6 months since prior 5-alpha reductase inhibitor treatment
- •Other concurrent hormonal therapy
- •Any concurrent radiotherapy
- •Testosterone at screening <= 1.7 mM or 50 ng/dL
- •Clinically significant elevation of serum creatinine or liver enzymes
- •Hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate
- •Hypersensitivity to CASODEXâ 50 mg.
研究组 & 干预措施
Continuous Androgen Deprivation (CAD)
Active Comparator
干预措施: leuprorelin acetate (Drug)
Intermittent Androgen Deprivation (IAD)
Experimental
干预措施: leuprorelin acetate (Drug)
结局指标
主要结局
Time to PSA progression
时间窗: 3 Years
次要结局
- Overall survival(5 Years)
- World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status(3 Years)
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25(3 Years)
- Time to serum testosterone > 50 ng/dL(3 Years)
- Change in progression biomarkers (some sites)(3 Years)
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