Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer Recurrent; Prostate Cancer (Diagnosis); Prostate Cancer Patients Who Have Brachytherapy Seed Implant; Prostate Cancer Patients Treated by Radiotherapy

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Claudia Schweizer, MD; Phone Number: +49 9131 85 33968; Email: claudia.schweizer@uk-erlangen.de
• Study Contact Backup: Name: Anna-Jasmina Donaubauer, Dr. rer. nat.

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Not yet recruiting
      • Klinik für Strahlentherapie
      • Contact: Klinik für Strahlentherapie Augsburg; Phone Number: +49 821 400-2080; Email: strahlenklinik@uk-augsburg.de
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Strahlenklinik Erlangen
      • Contact: Strahlenklinik Erlangen Ambulanz; Phone Number: +4991318534080; Email: sekretariat.strahlenklinik@uk-erlangen.de
    • Munich, Bavaria, Germany, 81377
      • Not yet recruiting
      • Klinik und Poliklinik für Strahlentherapie und Radioonkologie
      • Contact: Klinik und Poliklinik für Strahlentherapie und Radioonkologie; Phone Number: +49 (0)89 / 4400 - 73770; Email: strahl.onlinetermine@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Prostate cancer patients planning to undergo sole brachytherapy treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related toxicity	Acute toxicity related to brachytherapy	Up to 6 months
recurrence-free survival	recurrence-free survival	Up to 6 months
Overall survival	Overall survival	Up to 6 months

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: Ludwig-Maximilians - University of Munich; University Hospital Augsburg; Bavarian Cancer Research Center (BZKF)
• Investigators: Principal Investigator: Claudia Schweizer, MD, Strahlenklinik Universitätsklinikum Erlangen; Principal Investigator: Anna-Jasmina Donaubauer, Dr. rer. nat., Strahlenklinik Universitätsklinikum Erlangen

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: August 3, 2025
• First Submitted That Met QC Criteria: August 17, 2025
• First Posted (Actual): August 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Immune-profiling in prostate cancer patients; brachytherapy for prostate cancer; interstitial brachytherapy for prostate cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease
• Other Study ID Numbers: ImmunBioProBrachy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No