Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-09-01
2028-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Missing interdisciplinary tumor conference advise for PSMA RLT
MALE
No
Sponsors
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University Hospital Augsburg
OTHER
Technical University of Munich
OTHER
German Research Foundation
OTHER
Wuerzburg University Hospital
OTHER
Responsible Party
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Kerstin Michalski
PD Dr. Kerstin Michalski
Principal Investigators
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Kerstin Michalski, MD
Role: PRINCIPAL_INVESTIGATOR
University hospital Wuerzburg - Department of Nuclear Medince
Rainer Claus, Prof.
Role: PRINCIPAL_INVESTIGATOR
University hospital Augsburg - Internal Medicine II
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Role: backup
Role: backup
Other Identifiers
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GZ: MI 3238/1-1
Identifier Type: -
Identifier Source: org_study_id
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