ACTRN12615000912583已完成1 期
For men with metastatic prostate cancer refractory to hormonal and chemotherapy, what is the efficacy and toxicity of radionuclide therapy with Lutetium-177 PSMA
Peter MacCallum Cancer Centre0 个研究点目标入组 30 人开始时间: 2015年9月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1. Pathologically confirmed prostate adenocarcinoma
- •2. Castration-resistant metastatic disease
- •3. Prior treatment with Abiraterone, Enzalutamide or both (unless contraindicated, medically unsuitable or patient refuses)
- •4. Prior Taxane-based chemotherapy (unless contraindicated, medically unsuitable or patient refuses)
- •5. Documented prostate cancer progression within last 12 months as defined by radiographic progression (soft tissue disease by RECIST v1.1 criteria OR two or more documented new metastases on a bone scan) OR new pain in an area of radiographically evident disease
- •6. PSMA PET/CT demonstrating uptake intensity significantly greater than liver at sites of disease
- •7. Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2
- •8. Life expectancy > 12 weeks
排除标准
- •1. Poor kidney function or kidney obstruction (estimated GFR < 40 ml/min, hydronephrosis)
- •2. Poor blood counts (platelet count < 75,000 x10^9 /L, neutrophil count < 1.5 x 10^9 /L, or Hb < 9.0 g/dL)
- •3. Poor liver function (albumin <= 25)
- •4. FDG PET/CT demonstrating sites of major discordant disease (i.e. FDG + PSMA-)
- •5. Recent radiotherapy (within 6 weeks) to sole sites of assessable disease
- •6. Uncontrolled intercurrent illness that would limit compliance with study protocols
研究者
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