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NCT Number: NCT07131956

Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

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

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Key information

Conditions

Prostate Cancer (Diagnosis) Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Patients Treated by Radiotherapy Prostate Cancer Patients Who Have Brachytherapy Seed Implant Prostate Cancer Recurrent Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Klinik für Strahlentherapie, Augsburg, Bavaria, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy

    Time frame: 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

  1. Treatment-related toxicity

    Time frame: Up to 6 months

    Acute toxicity related to brachytherapy

  2. recurrence-free survival

    Time frame: Up to 6 months

    recurrence-free survival

  3. Overall survival

    Time frame: Up to 6 months

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Anna-Jasmina Donaubauer, Dr. rer. nat.

CONTACT

Claudia Schweizer, MD

CONTACT

[email protected]

+49 9131 85 33968

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Bavarian Cancer Research Center (BZKF)
  • Ludwig-Maximilians - University of Munich
  • University Hospital Augsburg

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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