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临床试验/NCT06460454
NCT06460454已完成不适用

PROnostic Interest of 18F-FDG PET/CT in Patients With Metastatic Castration-resistant Prostate Cancer (mCPRC) Progressing on Chemotherapy, Treated With 177 Lu-PSMA (PROFLu)D7 (± 1 Day)

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Diagnostic accuracy of 18FDG PET metabolic volume

研究概览

简要总结

The aim of this retrospective study was to assess the prognostic value of parameters extracted from 18FDG PET/CT and 68Ga-PSMA PET in the initial workup and follow-up of patients treated with 177Lu-PSMA in mCRPC.

详细描述

Prostate-specific membrane antigen (PSMA) is expressed in most metastatic castration-resistant prostate cancer (mCRPC) cells. In response to this finding, a vectorized internal radiotherapy (VIR) therapy was developed, lutetium 177-labeled PSMA, 177Lu-PSMA. Clinical trials have demonstrated its efficacy in men with metastatic castration-resistant prostate cancer . The number of patients treated in nuclear medicine departments has increased considerably in recent years, notably with the Food and Drug Administration's (FDA) and the European Medicines Agency's (EMA) approval of this treatment (177Lu-PSMA-617, Pluvicto®) in the setting of progressive mCRPC after at least one line of 2nd-generation hormone therapy and one line of taxane chemotherapy.

Patients eligible for treatment benefit from pre-therapy 68Ga-PSMA positron emission tomography (PET/CT) to assess PSMA expression by cancer cells, but 18FDG PET/CT, although mentioned in the EANM guidelines, is not routinely performed. For treatment follow-up of prostate cancer patients, the PCWG3 (prostate cancer working group 3) currently recommends conventional imaging (CT scan and bone scan) (4) and makes no mention of metabolic imaging, even though some lesions are not detectable with conventional imaging. In addition, one study reported that a high metabolic volume 18FDG PET/CT scan as part of the pre-therapy work-up for mCRPC prior to the introduction of 177Lu-PSMA or Cabazitaxel therapy was associated with a poorer response to treatment.

The aim of this retrospective study was to assess the prognostic value of parameters extracted from 18FDG PET/CT and 68Ga-PSMA PET in the initial work-up and follow-up of patients treated with 177Lu-PSMA in mCRPC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients treated with 177Lu-PSMA for castration-resistant prostate cancer at Nancy University Hospital
  • Patients with 68Ga-PSMA and 18FDG PET scans as part of the initial workup and treatment follow-up

排除标准

  • Patients who did not give their consent to use their data retrospectively

结局指标

主要结局

Diagnostic accuracy of 18FDG PET metabolic volume

时间窗: 1 year

Diagnostic accuracy of 18FDG PET metabolic volume in predicting 1-year overall survival.

次要结局

  • Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean)(1 year)
  • Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax)(1 year)
  • Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch)(1 year)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

BOURSIER Caroline

Principal Investigator

Central Hospital, Nancy, France

研究点 (1)

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