ISRCTN74112318已完成3 期
A prospective randomised phase III study of observation versus screening MRI and preemptive treatment in castrate resistant prostate cancer patients with spinal metastasis
Institute of Cancer Research Experimental Cancer Medicine Centre0 个研究点目标入组 541 人开始时间: 2012年11月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 541
研究概览
简要总结
Results article in https://pubmed.ncbi.nlm.nih.gov/35279270/ (added 14/03/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Histologically / cytologically confirmed adenocarcinoma of the prostate or clinical diagnosis of prostate cancer with osteoblastic bone metastases and Prostate-specific antigen (PSA) = 100ng/ml
- •2. Castrate resistant disease*
- •3. One or more spinal metastasis on imaging (technetium bone scan with confirmatory X-ay as appropriate clinically) undertaken at any time during the patient?s illness
- •4. Life expectancy of 6 months or more
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 02
- •6. Written, informed consent
- •*(rising PSA (> 5 ng /ml and >50% rise from nadir) after luteinizing hormone releasing hormone agonist (LHRHa) therapy or orchidectomy with or without antiandrogen)
排除标准
- •1. Back pain related to metastatic cancer, requiring regular (daily) analgesics
- •2. Previous active malignancy within the last 5 years other than basal cell carcinoma or low grade superficial bladder cancer
- •3. Current or previous spinal cord compression (SCC) or neurologic deficit
- •4. Brain metastasis
- •5. Spinal MRI within last 12 months
- •6. CT or PET CT scan of thorax AND abdomen within the last 6 months
- •7. Previous external beam radiotherapy to the vertebra or spinal surgery with the primary aim to prevent or treat SCC+
- •8. Serious or uncontrolled coexistent non-malignant diseases
- •9. Any contra indications for MRI
- •10. Inability to comply with neurologic and Quality of Life (QoL) assessments
- •11. Previous palliative radiotherapy to painful spinal metastases in now asymptomatic patients is permissible
研究者
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