ISRCTN38477744已完成不适用
A double-blind placebo-controlled randomised trial of oral sodium clodronate for metastatic prostate adenocarcinoma
Medical Research Council (MRC) (UK)0 个研究点目标入组 311 人开始时间: 2000年4月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 311
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Proven histological diagnosis of prostate cancer or Prostate-Specific Antigen (PSA) more than 100 mg/l
- •2. Metastatic bone disease demonstrated on bone scan or skeletal radiographs (Stage M1b)
- •3. Patients commencing or clinically responding to initial hormone treatment with orchidectomy, Luteinising Hormone Releasing Hormone (LHRH) analogues, cyproterone acetate, flutamide or complete androgen blockade but with no previous hormone treatment
- •4. Normocalcaemic (serum calcium within the normal range of the centre)
- •5. WHO performance status of 0, 1 or 2
- •6. No concomitant or previous use of other bisphosphonates
- •7. Serum creatinine less than twice upper limit of normal range of centre
- •8. No administration of any investigational drug within 12 months
排除标准
- •Does not meet inclusion criteria
研究者
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