Prostate Cancer, Prostate Cancer Metastatic Castration-Resistant
Conditions
Keywords
mCRPC, PSMA, radioligand therapy, liquid biopsy, cfDNA
Brief 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.
Interventions
None listed
Sponsors
University Hospital Augsburg
Technical University of Munich
German Research Foundation
Wuerzburg University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prognostic value of LBx (precisely ctDNA) before PSMA RLT | 16-18 weeks | identification of responders (partial response and stable disease)/non-responders (progressive disease) after 2 cycles of PSMA RLT, time-to-event analysis that could provide insights into overall survival or progression-free survival based on ctDNA level |
| Comparison of response assessment using LBx with biochemical response (PSA) after 2 cycles of PSMA RLT | 16-18 weeks | — |
| Comparison of response assessment using LBx with imaging-based response (PSMA PET/CT) after 2 cycles of PSMA RLT | 16-18 weeks | — |
Countries
Germany
Contacts
Primary ContactKerstin Michalski, MD
Backup ContactRainer Claus, Prof.
Outcome results
None listed