ACTRN12623000073606尚未招募1 期
A Single-Arm, Open-Label, Prospective, Phase 0 Trial Evaluating the Safety and Efficacy of Salvage 177Lu-PSMA-I&T in Prostate Specific Antigen (PSA) Biochemical Failure After Radical Prostatectomy for High-Risk Prostate Cancer
Dr Anthony-Joe Nassour0 个研究点目标入组 10 人开始时间: 2023年1月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
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
- •Men who have undergone radical prostatectomy for National Comprehensive Cancer Network high or very high-risk prostate cancer.
- •Negative surgical margins on radical prostatectomy histopathology.
- •PSA initially undetectable following radical prostatectomy.
- •PSA biochemical failure – defined as greater than or equal to 0.20ng/mL
- •PSMA expressing prostate cancer on pre-operative 18F-DCFPyL PSMA PET/CT
- •18F-DCFPyL PSMA PET/CT demonstrating no evidence of uptake to suggest detectable residual or metastatic disease
- •No local recurrence on post-operative mpMRI
- •No artifact disrupting interpretation of initial prostate cancer imaging
- •Significant PSMA expressing tumour on initial staging
- •Ability to give written informed consent, participate in and comply with study
排除标准
- •Previous diagnosis of prostate cancer
- •Positive surgical margin on radical prostatectomy specimen pathology
- •Non-PSMA expressing prostate cancer (e.g. ductal or neuroendocrine)
- •Artifact disrupting interpretation of initial prostate cancer imaging (e.g. THR)
- •Presence of suspected metastatic disease on pre-operative and post-operative 18F-DCFPyL PSMA PET/CT scan or mpMRI
- •Undetectable serum testosterone
- •Contraindication to Gadolinium
- •Contraindication to 177Lu-PSMA therapy
研究者
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