NCT07118436Recruiting
Liquid Biopsy Under PSMA Radioligand Therapy
Liquid Biopsy as a Biomarker in Patients Treated With PSMA Radioligand Therapy
Source: ClinicalTrials.gov · Last updated 12 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 1 Sept 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Wuerzburg University Hospital
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07118436
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Sept 2024 to the primary completion date, Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Unwilling to adhere to study procedures
- Missing interdisciplinary tumor conference advise for PSMA RLT
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University hospital Wuerzburg - Department of Nuclear Medicine Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| TUM Klinikum rechts der Isar - Department of Nuclear medicine Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| University hospital Wuerzburg - Department of Nuclear Medicine Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.