EUCTR2006-000341-19-IT进行中（未招募）不适用
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 1,700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- • men with histologically or cytologically-confirmed prostate cancer current or prior radiographic (x-ray, magnetic resonance imaging [MRI] or computer tomography [CT]) evidence of at least 1 bone metastasis documented failure of at least one hormonal therapy as evidenced by a rising PSA (ie, 3 consecutive determinations, taken at least 2 weeks apart from one another, with the third measurement being 4.0 ng/dL and taken within 8 weeks prior to randomization) serum testosterone level of < 50 ng/dL due to either surgical or chemical castration administration of concurrent chemotherapy or hormonal therapy for metastatic prostate cancer is allowed during the study, however, the therapy must be initiated and remain unchanged 28 days or more before randomization to the study life expectancy > 6 months Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 adequate organ function as defined by the following criteria: - serum aspartate aminotransferase (AST) 5 x upper limit of normal (ULN) - serum alanine aminotransferase (ALT) 5 x ULN - serum total bilirubin 2 x ULN - creatinine clearance (Cockroft-Gault) 30 mL/min - albumin-adjusted serum calcium 2.0 mmol/L (8.0 mg/dL) and 2.9 mmol/L (11.5 mg/dL) before any study-specific procedure, the appropriate written informed consent must be obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- • current or prior IV bisphosphonate administration. Prior administration of oral bisphosphonates is allowed, but they must be discontinued prior to randomization to the study. prior administration of denosumab known brain metastases known impending fracture in the hip region, defined as evidence of osteolytic lesions with cortical bone destruction exceeding 50% in the femur history or current evidence of osteomyelitis or osteonecrosis of the jaw active dental or jaw condition that requires oral surgery Non healed dental/oral surgery planned invasive dental procedures (eg, tooth extraction) for the course of the study evidence of any of the following conditions per subject self report or medical chart review: - history of, or concurrent malignancy (other than prostate cancer, superficial bladder cancer (ie, stage < T1G3), or basal cell carcinoma) if active disease is <3 years before date of randomization - unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization - major surgery (including surgery to bone), or significant traumatic injury occurring within 4 weeks before randomization - known infection with human immunodeficiency virus - active infection with Hepatitis B virus or Hepatitis C virus any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results thirty days or less since receiving an unapproved (ie, no marketing authorization has been granted in that country) product or device in another clinical trial known sensitivity to any of the products to be administered during the study (eg,zoledronic acid, mammalian derived products, calcium or vitamin D)
研究者
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