Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 164
- 试验地点
- 50
- 主要终点
- Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.
研究概览
简要总结
The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.
详细描述
The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of prostate cancer
- •Need for androgen deprivation treatment for 1 year
- •Serum testosterone level ≥ 150 ng/dL
- •Life expectancy of at least 18 months
- •ECOG Performance status grades 0,1 or 2
排除标准
- •Hypersensitivity to leuprolide acetate or polylactic acid
- •History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- •History of hypogonadism
研究组 & 干预措施
1
干预措施: Leuprolide acetate (Drug)
结局指标
主要结局
Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.
时间窗: Day 32 through Week 52
次要结局
- Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.(Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit)
- Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty).(Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit)
- Change from baseline in prostate specific antigen (PSA).(Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit)
- Change from baseline in prostatic acid phosphatase (PAP).(Weeks 1, 12, 26, 40, 52 and Final Visit)