NCT00116753已完成2 期
An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
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
- 460
- 试验地点
- 55
- 主要终点
- Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study
研究概览
简要总结
The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.
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
- •Has given written consent before 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.
- •Has a histologically confirmed (Gleason graded) 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 undergone prostatectomy or radiotherapy with curative intention.
- •Is a male patient aged 18 years or over.
- •Has a baseline serum testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.
- •Has an ECOG (Eastern Cooperative Oncology Group) score of
- •Has a PSA value of 2 ng/mL.
- •Has a life expectancy of at least 13 months.
排除标准
- •Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to the Screening Visit.
- •Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from Screening Visit.
- •Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema.
- •Has hypersensitivity towards any component of the investigational medicinal product.
- •Has had a cancer disease within the last five years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
- •Has a known or suspected hepatic or symptomatic biliary disease.
- •Has elevated serum ALT level above upper level of normal range or serum total bilirubin level above upper level of normal range as measured by the laboratory at the Screening Visit.
- •Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient's participation 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 study 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 28 days preceding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study.
- •Has previously participated in any degarelix study.
研究组 & 干预措施
Degarelix 240@40/240@40 (1,3,6,9)
Active Comparator
240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
干预措施: Degarelix (Drug)
Degarelix 240@40/240@60(1,3,6,9)
Active Comparator
240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
干预措施: Degarelix (Drug)
Degarelix 240@40/240@60(1,4,7,10)
Active Comparator
240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
干预措施: Degarelix (Drug)
结局指标
主要结局
Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study
时间窗: From Day 28 to 12 or 13 months
Figure in the table give the number of participants with all testosterone values \<=0.5 ng/mL from Day 28 to the end of the study.
次要结局
- Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study(From after Day 28 to 12 or 13 months)
- Number of Participants With Testosterone <=0.5 ng/mL at Day 28(28 Days)
- Liver Function Tests(12 or 13 months)
- Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline(12 or 13 months)
研究者
研究点 (55)
Loading locations...
相似试验
已完成
2 期
Dose Finding Trial With a New Treatment (Degarelix) for Prostate CancerProstate CancerNCT00819156Ferring Pharmaceuticals189
已完成
3 期
A Trial of Degarelix in Patients With Prostate CancerProstate CancerNCT00946920Ferring Pharmaceuticals859
已完成
2 期
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate CancerProstate CancerNCT00819247Ferring Pharmaceuticals129
已完成
2 期
Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation TherapyProstate CancerNCT00468286Ferring Pharmaceuticals133
已完成
3 期
Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate CancerProstate CancerNCT01071915Ferring Pharmaceuticals157