Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

NCT07131956 — Recruiting, 200 participants, University of Erlangen-Nürnberg Medical School

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Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy (ImmunBioProBrachy)

Registry	NCT07131956
Status	Recruiting
Study type	Observational
Enrollment	200 (Estimated)
Sponsor	University of Erlangen-Nürnberg Medical School (Other); collaborators: Bavarian Cancer Research Center (BZKF), University Hospital Augsburg, Ludwig-Maximilians - University of Munich
Conditions	Prostate Cancer (Diagnosis), Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer Recurrent
Dates	start 2025-12-01 (estimated), primary completion 2028-07-31 (estimated), completion 2028-07-31 (estimated), first posted 2025-08-20, last updated 2025-11-18
Locations	3 sites in Germany

-Summary

Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.

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+Arms and interventions

Arm	Type	Interventions	Description
Primary brachytherapy			Patients receiving sole primary brachytherapy (either LDR-BT or HDR-BT) for low or low intermediate risk prostate cancer
Salvage brachytherapy			Patients receiving sole brachytherapy (either PDR-BT or HDR-BT) for locally recurrent prostate cancer after prior irradiation with prostate in situ

+Outcome measures

Primary outcomes

Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy [Blood withdrawal pre-brachytherapy treatment, during surgery, one day after brachytherapy and at the first follow-up visit 4-12 weeks later. Tissue samples at every brachytherapy procedure.]: Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy in the primary as well as in the recurrent setting.

Secondary outcomes

Treatment-related toxicity [Up to 6 months]: Acute toxicity related to brachytherapy
recurrence-free survival [Up to 6 months]: recurrence-free survival
Overall survival [Up to 6 months]: Overall survival

+Eligibility

Sex: Male, ages: 18 Years to any

Inclusion Criteria Arm 1:

* Primary treatment with I-125 seeds or HDR-BT
* No previous treatment for prostate cancer
* Age ≥ 18 years

Inclusion Criteria Arm 2:

* HDR- or PDR-BT
* No radiation therapy within three months before salvage treatment
* Complete documentation available on previous treatment for prostate cancer
* No history of prostatectomy
* Age ≥ 18 years

Exclusion Criteria:

* Pre-existent auto-immune disease
* patients under bloodthinning medication
* substance abuse

+Locations (3)

Facility	City	Country	Status
Klinik für Strahlentherapie	Augsburg, Bavaria	Germany	Not yet recruiting
Strahlenklinik Erlangen	Erlangen, Bavaria	Germany	Recruiting
Klinik und Poliklinik für Strahlentherapie und Radioonkologie	Munich, Bavaria	Germany	Not yet recruiting

+Investigators

Claudia Schweizer, MD, Principal investigator, Strahlenklinik Universitätsklinikum Erlangen
Anna-Jasmina Donaubauer, Dr. rer. nat., Principal investigator, Strahlenklinik Universitätsklinikum Erlangen