已完成 NCT00699751

一項針對有症狀且荷爾蒙難治性前列腺癌伴骨骼轉移患者使用Radium-223 dichloride的第三期研究

前列腺癌黑色素瘤膀胱癌/泌尿道上皮癌Phase III

ALSYMPCA(ALpharadin用於有症狀前列腺癌)是一項國際性第三期臨床研究,旨在評估Radium-223 dichloride於荷爾蒙難治性前列腺癌伴骨骼轉移患者中的療效與安全性。

適應症:Hormone Refractory Prostate Cancer、Bone Metastases

收案條件

納入條件

  • 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

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。