RecruitingNCT07118436

Liquid Biopsy Under PSMA Radioligand Therapy

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


Sponsor

Wuerzburg University Hospital

Enrollment

100 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study is using liquid biopsy — a blood test that detects cancer DNA — to monitor patients with advanced prostate cancer who are receiving PSMA radioligand therapy (a targeted radiation treatment). The goal is to understand how cancer DNA in the blood changes during treatment and whether it can help predict outcomes. **You may be eligible if...** - You have metastatic castration-resistant prostate cancer (mCRPC) that qualifies for PSMA radioligand therapy per standard guidelines - You have had a recent PSMA PET/CT scan (within 8 weeks before starting treatment) - You have received at least one prior hormone therapy and one prior taxane-based chemotherapy - You are 18 or older and can speak sufficient German (or have a translator) **You may NOT be eligible if...** - You are unwilling to follow study procedures - You have not had a multidisciplinary tumor board recommendation for PSMA radioligand therapy - You do not meet standard eligibility for PSMA therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(3)

University hospital Wuerzburg - Department of Nuclear Medicine

Augsburg, Germany

TUM Klinikum rechts der Isar - Department of Nuclear medicine

München, Germany

University hospital Wuerzburg - Department of Nuclear Medicine

Würzburg, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07118436


Related Trials