A Phase II Single Arm Study of Degarelix in Men With Castrate Resistant Prostate Cancer With a Rising Prostate-Specific Antigen (PSA) Despite LHRH Agonist Therapy.
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 50% fall in PSA
研究概览
简要总结
Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).
详细描述
To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.
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
- •histologically confirmed adenocarcinoma of the prostate
- •currently receiving LHRH agonist
- •Anti-androgen oral therapy is permitted but will be discontinued upon enrollment
- •PSA > 2 ng/ml
- •rising PSA despite LHRH agonist
- •patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only
- •Prior chemotherapy allowed
- •ECOG performance status 0-1
排除标准
- •Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.
- •Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent
研究组 & 干预措施
Degarelix
Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.
干预措施: Degarelix (Drug)
结局指标
主要结局
50% fall in PSA
时间窗: 8 weekly
Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist
次要结局
- Luteinizing hormone (LH)(8 weekly)
- Follicle stimulating hormone (FSH)(8 weekly)
- Testosterone (TT)(8 weekly)
- dehydroepiandrosterone (DHEA)(8 weekly)
- dehydroepiandrosterone-sulfate (DHEA-S)(8 weekly)
- androstenedione (AED)(8 weekly)
- dihydrotestosterone (DHT)(8 weekly)
研究者
Kim Chi
Associate Professor of Medicine, University of British Columbia
British Columbia Cancer Agency