Liquid Biopsy Under PSMA Radioligand Therapy

NCT07118436 | Recruiting

• 1 other identifier: GZ: MI 3238/1-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer Metastatic Castration-Resistant; Prostate Cancer

Keywords

mCRPC; PSMA; radioligand therapy; liquid biopsy; cfDNA

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Unwilling to adhere to study procedures
• Missing interdisciplinary tumor conference advise for PSMA RLT

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• University Hospital Augsburg: collaborator
• Technical University of Munich: collaborator
• German Research Foundation: collaborator

Study Sites (3)

University hospital Wuerzburg - Department of Nuclear Medicine

Augsburg, Germany

RECRUITING

TUM Klinikum rechts der Isar - Department of Nuclear medicine

München, Germany

RECRUITING

University hospital Wuerzburg - Department of Nuclear Medicine

Würzburg, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kerstin Michalski, MD

  University hospital Wuerzburg - Department of Nuclear Medince

  PRINCIPAL INVESTIGATOR

• Rainer Claus, Prof.

  University hospital Augsburg - Internal Medicine II

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerstin Michalski, MD

CONTACT

+4993120135931; michalski_k@ukw.de

Rainer Claus, Prof.

CONTACT

Rainer.Claus@uk-augsburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 40 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Kerstin Michalski

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

DE (3)