Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07131956

Enrollment

200

Registered

2025-08-20

Start date

2025-12-31

Completion date

2028-07-31

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer (Diagnosis), Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Recurrent

Keywords

Immune-profiling in prostate cancer patients, brachytherapy for prostate cancer, interstitial brachytherapy for prostate cancer

Brief summary

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Contacts

Primary ContactClaudia Schweizer, MD

claudia.schweizer@uk-erlangen.de+49 9131 85 33968

Backup ContactAnna-Jasmina Donaubauer, Dr. rer. nat.

Outcome results