Blood-based tumor DNA testing during PSMA radioligand therapy
Liquid Biopsy as a Biomarker in Patients Treated With PSMA Radioligand Therapy
Wuerzburg University Hospital · NCT07118436
This project will test whether blood-based liquid biopsies taken before, during, and after PSMA radioligand therapy can help predict outcomes for men with metastatic castration-resistant prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | Male |
| Sponsor | Wuerzburg University Hospital (other) |
| Locations | 3 sites (Augsburg and 2 other locations) |
| Trial ID | NCT07118436 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with metastatic castration-resistant prostate cancer who are eligible for PSMA radioligand therapy, have had prior antiandrogen and taxane therapy, and can provide informed consent and attend the participating German centers.
Not a fit: Patients who are not eligible for PSMA radioligand therapy, cannot provide serial blood samples, lack detectable ctDNA, or cannot attend the participating sites are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could let doctors use simple blood tests to monitor response to PSMA radioligand therapy and detect emerging resistance earlier.
How similar studies have performed: Previous work has shown ctDNA can reflect tumor burden and predict outcomes in mCRPC, but applying serial liquid biopsies specifically during PSMA radioligand therapy is relatively new and still being validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Augsburg and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer Metastatic Castration-Resistant, Prostate Cancer, mCRPC, PSMA, radioligand therapy, liquid biopsy, cfDNA