Liquid Biopsy Under PSMA Radioligand Therapy | NCT07118436

Studies
Liquid Biopsy Under PSMA Radioligand Therapy

NCT07118436

Sponsor

Wuerzburg University Hospital

Status

Recruiting

Last Update Posted

Aug 12, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Prostate Cancer Metastatic Castration-Resistant
Prostate Cancer

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Aug 2028Estimated

First Submitted Date

Jul 28, 2025

First Submission Date that Met QC Criteria

Aug 8, 2025

First Posted Date

Aug 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2025

Last Update Posted Date

Aug 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kerstin Michalski, PD Dr. Kerstin Michalski, Wuerzburg University HospitalPrincipal Investigator

Lead Sponsor

Wuerzburg University HospitalOTHER

Collaborators

Name	Class
University Hospital Augsburg	OTHER
Technical University of Munich	OTHER
German Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

40 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prognostic value of LBx (precisely ctDNA) before PSMA RLT	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	16-18 weeks
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with metastatic castration-resistant prostate cancer undergoing PSMA radioligand therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kerstin Michalski, MD	Contact	+4993120135931		michalski_k@ukw.de
Rainer Claus, Prof.	Contact			Rainer.Claus@uk-augsburg.de

Overall Officials

Name	Affiliation	Role
Kerstin Michalski, MD	University hospital Wuerzburg - Department of Nuclear Medince	Principal Investigator
Rainer Claus, Prof.	University hospital Augsburg - Internal Medicine II	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Wuerzburg - Department of Nuclear Medicine	Recruiting	Augsburg			Germany

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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Browse Branches

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