Liquid Biopsy Under PSMA Radioligand Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer Metastatic Castration-Resistant, Prostate Cancer. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Liquid Biopsy as a Biomarker in Patients Treated With PSMA Radioligand Therapy
Overview
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.
Primary outcome measures
- Prognostic value of LBx (precisely ctDNA) before PSMA RLT [Time frame: 16-18 weeks]
- Comparison of response assessment using LBx with biochemical response (PSA) after 2 cycles of PSMA RLT [Time frame: 16-18 weeks]
- Comparison of response assessment using LBx with imaging-based response (PSMA PET/CT) after 2 cycles of PSMA RLT [Time frame: 16-18 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Unwilling to adhere to study procedures
- Missing interdisciplinary tumor conference advise for PSMA RLT
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- University hospital Wuerzburg - Department of Nuclear Medicine — Augsburg
- TUM Klinikum rechts der Isar - Department of Nuclear medicine — München
- University hospital Wuerzburg - Department of Nuclear Medicine — Würzburg
Identifiers
NCT: NCT07118436 · GZ: MI 3238/1-1