An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 288
- 试验地点
- 62
- 主要终点
- Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin
研究概览
简要总结
A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
详细描述
CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920).
In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).
It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms).
The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
- •Has completed the CS35 trial.
排除标准
- •Has been withdrawn from the CS35 trial.
- •Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
研究组 & 干预措施
Degarelix 240 mg/480 mg
干预措施: Degarelix (Drug)
Goserelin acetate
干预措施: Goserelin acetate (Drug)
结局指标
主要结局
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin
时间窗: From baseline to 3 years
PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.
次要结局
- Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin(From baseline to 3 years)
- Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin(From baseline to 3 years)
- Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin(From baseline to 3 years)
- Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin(From baseline to 3 years)
- Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin(From baseline to 3 years)
- Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin(Baseline and after 1, 6, 12, 19, and 22 months)
- Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin(Baseline and after 1, 6, 12, 19, and 22 months)