已完成 NCT00699751

一项针对有症状且激素难治性前列腺癌伴骨骼转移患者使用Radium-223 dichloride的第三期研究

前列腺癌黑色素瘤膀胱癌/尿路上皮癌Phase III

ALSYMPCA(ALpharadin用于有症状前列腺癌)是一项国际性第三期临床研究,旨在评估Radium-223 dichloride于激素难治性前列腺癌伴骨骼转移患者中的疗效与安全性。

适应症:Hormone Refractory Prostate Cancer、Bone Metastases

入组条件

纳入标准

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Known hormone refractory disease
  • Multiple skeletal metastases (≥ 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 EBRT (External Beam Radiation Therapy) 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 CT or chest x-ray within previous 8 weeks

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。