An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 859
- 试验地点
- 124
- 主要终点
- Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
研究概览
简要总结
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.
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
- •18 years or older.
- •Has a histological confirmed prostate cancer Gleason graded).
- •Has a screening testosterone above 2.2 ng/mL.
- •Rising prostate-specific antigen (PSA).
- •Has Eastern Cooperative Oncology Group (ECOG) score of ≤
- •Has a life expectancy of at least one year.
排除标准
- •Current or previous hormone therapy.
- •Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
- •Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- •Has a heart insufficiency.
- •Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
- •Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- •Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
- •Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
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
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
时间窗: From Day 28 to Day 364
This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
时间窗: Day 3 to Day 364
This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.
次要结局
- Serum Levels of Testosterone Over Time(Baseline and after 1, 2, 3, 6 and 13 months)
- Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time(Baseline and after 1, 2, 3, 6 and 13 months)
- Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline(At baseline, 10 months and 13 months)
- Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline(At baseline, 1 month, 4 months, 7 months and 13 months)