跳至主要内容
临床试验/NCT07118436
NCT07118436招募中不适用

Liquid Biopsy as a Biomarker in Patients Treated With PSMA Radioligand Therapy

Wuerzburg University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Prognostic value of LBx (precisely ctDNA) before PSMA RLT

研究概览

简要总结

Prostate cancer is the second most common cause of cancer death in men worldwide. After exhausting guideline-compliant therapies or in accordance with the approval of 177Lu-PSMA-617 (Pluvicto®), patients with metastatic castration-resistant prostate cancer (mCRPC) can be offered radioligand therapy (RLT) that targets the prostate-specific membrane antigen (PSMA). Despite an initially high response rate to PSMA-RLT, the disease often progresses rapidly again. The underlying mechanisms are still poorly understood.

Liquid biopsy (LBx) involves the collection and analysis of body fluids, particularly blood. Its major advantage compared to a tissue sample is its non-invasive nature, allowing for multiple samplings, as well as the examination of more than just a single punctured lesion. Among other things, circulating tumor DNA (ctDNA) can be detected in the blood.

The aim of this study is to apply LBx before, during, and after PSMA-RLT in patients with mCRPC to determine prognostic factors before therapy and to assess the value of LBx in evaluating treatment response. Furthermore, LBx will be used to gather information on the course of potential tumor heterogeneities and to determine resistance mechanisms against PSMA-RLT.

To this end, patients receiving PSMA-RLT will be enrolled in the study at three sites (University Hospital Wuerzburg, University Hospital Augsburg, Klinikum rechts der Isar Munich). The evaluation of clinical and imaging parameters will be carried out centrally at the University Hospital Wuerzburg, while the analysis of LBx will be performed at the University Hospital Augsburg.

研究设计

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

入排标准

性别
Male
接受健康志愿者

入选标准

  • Patients with mCRPC eligble for PSMA RLT
  • In-lable use for PSMA RLT
  • PSMA PET/CT not older than 8 weeks prior to first cycle of PSMA RLT
  • One previous line of antiandrogen receptor pathway treatment and one previous line of taxan based therapy
  • Age ≥ 18 years
  • Written informed consent
  • Sufficient knowledge of the German language or presence of a translator

排除标准

  • Unwilling to adhere to study procedures
  • Missing interdisciplinary tumor conference advise for PSMA RLT

结局指标

主要结局

Prognostic value of LBx (precisely ctDNA) before PSMA RLT

时间窗: 16-18 weeks

identification of responders (partial response and stable disease)/non-responders (progressive disease) after 2 cycles of PSMA RLT, time-to-event analysis that could provide insights into overall survival or progression-free survival based on ctDNA level

Comparison of response assessment using LBx with biochemical response (PSA) after 2 cycles of PSMA RLT

时间窗: 16-18 weeks

Comparison of response assessment using LBx with imaging-based response (PSMA PET/CT) after 2 cycles of PSMA RLT

时间窗: 16-18 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kerstin Michalski

PD Dr. Kerstin Michalski

Wuerzburg University Hospital

研究点 (2)

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