Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

NCT07131956 | Recruiting

• 1 other identifier: ImmunBioProBrachy
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

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

  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 Outcomes (3)

• Treatment-related toxicity

  Up to 6 months

• recurrence-free survival

  Up to 6 months

• Overall survival

  Up to 6 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prostate cancer patients planning to undergo sole brachytherapy treatment

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Bavarian Cancer Research Center (BZKF): collaborator
• University Hospital Augsburg: collaborator
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (3)

Klinik für Strahlentherapie

Augsburg, Bavaria, 86156, Germany

NOT YET RECRUITING

Strahlenklinik Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Munich, Bavaria, 81377, Germany

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

wohle blood, prostate tissue samples

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Schweizer, MD

  Strahlenklinik Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

• Anna-Jasmina Donaubauer, Dr. rer. nat.

  Strahlenklinik Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Schweizer, MD

CONTACT

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

Anna-Jasmina Donaubauer, Dr. rer. nat.

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Claudia Schweizer MD

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)