Immune biomarker testing for men receiving prostate brachytherapy
Official title: Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy (ImmunBioProBrachy)
Run by University of Erlangen-Nürnberg Medical School · NCT07131956 · Data updated 2026-11-12
This project will test how immune cells in blood and tumor tissue change before, during, and after brachytherapy in men treated for prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 200 (estimated) |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Augsburg, Bavaria and 2 other locations) |
| Status | Recruiting |
| Started | December 2025 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT07131956 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men aged 18 or older with prostate cancer who are scheduled for primary I-125 seed or HDR brachytherapy, or for salvage HDR/PDR brachytherapy with complete prior treatment records and no prior prostatectomy, are ideal candidates.
✕Probably not a fit
Patients with pre-existing autoimmune disease, those taking blood-thinning medications, people with substance abuse, or those not receiving brachytherapy are unlikely to participate or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, multi-center study collects blood samples before, during, and after brachytherapy and obtains tissue samples during the brachytherapy procedure for detailed immune profiling. It includes two arms: primary treatment with I-125 seeds or HDR brachytherapy, and salvage HDR/PDR brachytherapy with documented prior treatments and no recent radiotherapy within three months. Key exclusions include pre-existing autoimmune disease, use of blood-thinning medication, and substance abuse. The goal is to map peripheral and tumor immune changes associated with brachytherapy to identify candidate biomarkers for future clinical use.
Why it matters
Potential benefit: If successful, the findings could identify immune markers that help predict response or guide future immunotherapy strategies for prostate cancer patients treated with brachytherapy.
How similar studies have gone: Previous radiation oncology studies have shown that radiotherapy can alter systemic and tumor immune profiles, but detailed immune-profiling specifically in brachytherapy-treated prostate cancer patients has been limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Strahlenklinik Erlangen
Erlangen, Bavaria, Germany Recruiting -
Klinik für Strahlentherapie
Augsburg, Bavaria, Germany Not yet recruiting -
Klinik und Poliklinik für Strahlentherapie und Radioonkologie
Munich, Bavaria, Germany Not yet recruiting
Study contacts
- Principal investigator: Claudia Schweizer, MD — Strahlenklinik Universitätsklinikum Erlangen
- Study coordinator: Claudia Schweizer, MD
- Email: claudia.schweizer@uk-erlangen.de
- Phone: +49 9131 85 33968
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.