NCT00738673已完成2 期
An Open-Label, Multi-Centre, Uncontrolled, Exploratory Trial Investigating Degarelix One-Month Dosing Regimen as Second-Line Hormonal Treatment After PSA-Failure in GnRH Agonist Treated 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
- 37
- 试验地点
- 4
- 主要终点
- Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
研究概览
简要总结
This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient has given written informed consent before any trial-related activity is performed.
- •Patient is 18 years or older.
- •Histologically confirmed prostate cancer.
- •Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due).
- •Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months.
- •Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Estimated life expectancy at least 12 months.
排除标准
- •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.
- •Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
- •Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
- •Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
- •Known hypersensitivity towards any component of the investigational medical product.
- •History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- •Known or suspected clinically significant liver and/or biliary disease.
- •Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- •Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, 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.
- •Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
- •Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
- •Previous participation in any degarelix trial.
研究组 & 干预措施
Degarelix
Experimental
Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0.
Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
干预措施: degarelix (Drug)
结局指标
主要结局
Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
时间窗: Day 0 (baseline), 3 months
Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level
次要结局
- Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline(Day 0 (baseline), 1 month)
- Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline(Day 0 (baseline), 2 months)
- Participants at Testosterone Castrate Level Throughout the Study(up to month 12)
- Change From Baseline in Serum Levels of Testosterone at the Last Visit(Day 0 (baseline), up to month 12 (last visit))
- Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit(Day 0 (baseline), up to month 12 (last visit))
- Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit(Day 0 (baseline), up to month 12 (last visit))
- Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit(Day 0 (baseline), up to month 12 (last visit))
- Participants at Testosterone Level <=0.2 ng/mL Throughout the Study(up to month 12)
- Participants at Testosterone Level <=0.32 ng/mL Throughout the Study(up to month 12)
- Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study(up to month 12)
- Kaplan-Meier Estimate for Overall Survival(up to month 12)
研究者
研究点 (4)
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