Actively Recruiting
Liquid Biopsy Under PSMA Radioligand Therapy
Led by Wuerzburg University Hospital · Updated on 2025-08-12
100
Participants Needed
3
Research Sites
204 weeks
Total Duration
On this page
Sponsors
W
Wuerzburg University Hospital
Lead Sponsor
U
University Hospital Augsburg
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Liquid Biopsy Under PSMA Radioligand Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic castration-resistant prostate cancer eligible for PSMA radioligand therapy
- Use of PSMA radioligand therapy according to label
- PSMA PET/CT scan performed within 8 weeks before first PSMA RLT cycle
- At least one prior antiandrogen receptor pathway therapy and one prior taxane-based therapy
- Age 18 years or older
- Written informed consent provided
- Sufficient German language skills or presence of a translator
You will not qualify if you...
- Unwillingness to follow study procedures
- Lack of interdisciplinary tumor conference recommendation for PSMA radioligand therapy
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University hospital Wuerzburg - Department of Nuclear Medicine
Augsburg, Germany
Actively Recruiting
2
TUM Klinikum rechts der Isar - Department of Nuclear medicine
München, Germany
Actively Recruiting
3
University hospital Wuerzburg - Department of Nuclear Medicine
Würzburg, Germany
Actively Recruiting
Research Team
K
Kerstin Michalski, MD
CONTACT
R
Rainer Claus, Prof.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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