NCT00116779已完成2 期
An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 35
- 主要终点
- Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
研究概览
简要总结
The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.
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
- •Each patient must meet the following inclusion criteria before entry into the study.
- •Has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
- •Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention.
- •Male patient aged 18 years or over.
- •Has a baseline testosterone above the lower limit of normal range.
- •Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than
- •Has a PSA value of greater than or equal to 2ng/mL.
排除标准
- •Any patient meeting one or more of the following exclusion criteria will not be entered into the study.
- •Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens). However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit.
- •Currently or recently (within the last 12 weeks preceding the Screening Visit) under treatment with any other drug modifying testosterone level or function.
- •Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit.
- •Has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or Quincke's Edema.
- •Has hypersensitivity towards any component of the investigational products (degarelix or mannitol).
- •Has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
- •Has elevated serum ALT level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the Screening Visit.
- •Has known or suspect hepatic disease of any sort. Patients with liver disease are not to be enrolled in this study.
- •Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results.
- •Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator.
- •Has a mental incapacity or language barriers precluding adequate understanding or cooperation.
- •Has received an investigational drug within the last 12 weeks preceding Screening Visit.
- •Has previously participated in any degarelix study
研究组 & 干预措施
Degarelix 60mg
Experimental
Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
干预措施: Degarelix (Drug)
Degarelix 80mg
Experimental
Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
干预措施: Degarelix (Drug)
结局指标
主要结局
Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
时间窗: Day 28 to Day 364
Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364
Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28
时间窗: Day 28 - Day 364
Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364.
次要结局
- Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.(Day 3)
- Days to 50 Percent and 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 Di-Hydrotestosterone Levels At Various Study Timepoints(Baseline, Days 1, 3, 7, 14)
- Median Prostate-Specific Antigen Values at Various Study Timepoints(Baseline, Days 3, 14, 28, 84, 364)
- Median Luteinizing Hormone Levels at Various Study Timeframes(Baseline, Days 1, 3, 7, 14)
- Median Testosterone Levels at Various Days During the Study(Baseline, Days 1,3,7,14,364)
- Number of Participants With Abnormal Alanine Aminotransferase Values(Day 1 through day 364)
- Number of Participants With Abnormal Aspartate Aminotransferase Values(Day 1 - 364)
- Number of Participants With Abnormal Total Bilirubin Values(Day 1 - 364)
- Participants With Markedly Abnormal Changes in Vital Signs or Body Weight(Day 364)
研究者
研究点 (35)
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