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NCT Number: NCT07118436

Liquid Biopsy Under PSMA Radioligand Therapy

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.

Recruiting

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Key information

Sex eligibility

Male

Study type

Observational

Primary location

University hospital Wuerzburg - Department of Nuclear Medicine, Augsburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prognostic value of LBx (precisely ctDNA) before PSMA RLT

    Time frame: 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

  2. Comparison of response assessment using LBx with biochemical response (PSA) after 2 cycles of PSMA RLT

    Time frame: 16-18 weeks

  3. Comparison of response assessment using LBx with imaging-based response (PSMA PET/CT) after 2 cycles of PSMA RLT

    Time frame: 16-18 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Kerstin Michalski, MD

CONTACT

[email protected]

+4993120135931

Rainer Claus, Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • German Research Foundation
  • Technical University of Munich
  • University Hospital Augsburg

Registry information

Official study title

Liquid Biopsy as a Biomarker in Patients Treated With PSMA Radioligand Therapy

Acronym: LOOPS

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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