Blood-based tumor DNA testing during PSMA radioligand therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will collect serial blood samples for circulating tumor DNA (ctDNA) analysis from men with mCRPC who are receiving PSMA-targeted radioligand therapy. Samples will be obtained before the first cycle, during treatment, and after completion to look for molecular changes that correlate with response or early progression. Clinical data including recent PSMA PET/CT, prior therapies, and outcomes will be correlated with liquid biopsy findings. The work is conducted at several German university hospitals and uses non-invasive serial sampling to explore prognostic markers.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Principal investigator: Kerstin Michalski, MD — University hospital Wuerzburg - Department of Nuclear Medince
• Study coordinator: Kerstin Michalski, MD
• Email: michalski_k@ukw.de
• Phone: +4993120135931

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.