ACTRN12609000262202进行中（未招募）3 期
A double-blind, randomised, multiple dose, phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases, with the primary efficacy endpoint being overall survival.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Algeta ASA
- 入组人数
- 921
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate - Known hormone refractory disease - Multiple skeletal metastases (greater than or equal to 2 hot spots) on bone scintigraphy - No intention to use cytotoxic chemotherapy within the next 6 months - Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with external beam radiation therapy (EBRT) for bone pain
排除标准
- •- Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
- •- Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
- •- Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago
- •- Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
- •- Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
- •- History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic computed tomography (CT) or chest x-ray within previous 8 weeks
研究者
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