An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 38
- 主要终点
- Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
研究概览
简要总结
The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.
详细描述
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
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
- •Written informed consent prior to any study related procedures
- •Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
- •ECOG score to be equal to or above 2
- •Testosterone level within age-specific normal range
- •PSA value equal to or above 2 ng/ml
- •Life expectancy of at least 6 months
排除标准
- •Previous or current hormonal treatment of prostate cancer
- •Recent or current treatment with any drugs modifying the testosterone level
- •Candidate for curative treatment such as prostatectomy or radiotherapy
- •History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
- •Hypersensitivity towards any component of degarelix or mannitol
- •Cancer disease within the last 5 years except for prostate cancer and some skin cancers
- •Signs of liver impairment shown as elevated serum ALT or serum bilirubin
- •Known hepatic disease
- •Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
- •Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
- •Mental incapacity or language barrier precluding adequate understanding or cooperation
- •Having received an investigational product within the last 12 weeks preceding the trial
- •Previous participation in this trial
研究组 & 干预措施
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
干预措施: degarelix (Drug)
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
干预措施: degarelix (Drug)
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
干预措施: degarelix (Drug)
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
干预措施: degarelix (Drug)
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
干预措施: degarelix (Drug)
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
干预措施: degarelix (Drug)
结局指标
主要结局
Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
时间窗: 12 months
Number of patients who achieved a testosterone level considered a castration level.
次要结局
- Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.(Day 3)
- Days to 50 Percent Reduction in Prostate-Specific Antigen(Day 0 (post dose) to Day 364)
- Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28(Day 28 - 364)
- Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.(Day 28)
- Days to 90 Percent Reduction in Prostate-Specific Antigen(Day 0 (post dose) to Day 364)
- Days to Prostate-Specific Antigen Progression(Day 0 (post dose) to Day 364)
- Median Serum Testosterone Levels(Day 0 (Baseline), Days 1,3,7,14, and 364)
- Median Prostate-specific Antigen Levels(Day 0 (Baseline), Days 3, 7, 14, and 364)
- Median Values of Di-Hydrotestosterone(Day 0 (Baseline), Days 1, 3, 7, 14, and 364)
- Median Values for Serum Luteinizing Hormone(Day 0 (Baseline), Days 1, 3, 7, 14, and 364)
- Median Values for Follicle Stimulation Hormone(Day 0 (Baseline), Days 1, 3, 7, 14, and 364)
- The Number of Patients With Abnormal Liver Function Tests(364 days)
- The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight(Day 364)