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临床试验/NL-OMON48796
NL-OMON48796已完成3 期

Repeated Rhenium-188-HEDP versus Radium-223-chloride in patients with metastatic castration-resistant prostate cancer: the RARE study. - RaRe

Vrije Universiteit Medisch Centrum0 个研究点目标入组 402 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
402

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

年龄范围
18 至 64(—)

入选标准

  • - male, 18 years and older
  • - histologically confirmed prostate cancer
  • - bone metastases (*6 lesions) with pathological uptake at bone scintigraphy
  • - WHO performance status *2
  • - life expectancy at least 6 months
  • - castration resistant disease (testosterone level *1.7nmol/L)
  • - Progression on or after two previous treatments (other than LHRH analogues) including docetaxel), or inability to receive other treatments.
  • - baseline PSA * 5 ng/ml with evidence of progressively increasing PSA
  • - symptomatic disease with either regular use of analgesic medication or treatment with external beam radiotherapy within the previous 12 weeks
  • - adequate renal and hematologic function
  • - written informed consent

排除标准

  • - treatment with chemotherapy within the previous 4 weeks
  • - treatment with abiraterone and enzalutamide within the previous 5 days
  • - Previous hemibody external radiotherapy
  • - systemic radiotherapy with radioisotopes within the previous 24 weeks
  • - malignant lymhpadenopathy * 3cm in short axis diameter
  • - presence of visceral metastases
  • - imminent of established spinal cord compression
  • - active uncontrolled infections
  • - history of another malignancy within the last 5 years except adequatly treated basal cell carcinoma of the skin
  • - any serious uncontrolled concomitant disease

研究者

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