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Liquid Biopsy Under PSMA Radioligand Therapy

NCT07118436 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-08-12

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • University Hospital Augsburg

    collaborator OTHER

  • Technical University of Munich

    collaborator OTHER

  • German Research Foundation

    collaborator OTHER

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Kerstin Michalski, MD · University hospital Wuerzburg - Department of Nuclear Medince

  • Rainer Claus, Prof. · University hospital Augsburg - Internal Medicine II

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-12-31
Completion
2028-08-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118436 on ClinicalTrials.gov