Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

NCT ID: NCT07131956

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-07-31

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary brachytherapy

Patients receiving sole primary brachytherapy (either LDR-BT or HDR-BT) for low or low intermediate risk prostate cancer

No interventions assigned to this group

Salvage brachytherapy

Patients receiving sole brachytherapy (either PDR-BT or HDR-BT) for locally recurrent prostate cancer after prior irradiation with prostate in situ

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Pre-existent auto-immune disease
* patients under bloodthinning medication
* substance abuse
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bavarian Cancer Research Center (BZKF)

UNKNOWN

Sponsor Role collaborator

University Hospital Augsburg

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Claudia Schweizer

Claudia Schweizer MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Schweizer, MD

Role: PRINCIPAL_INVESTIGATOR

Strahlenklinik Universitätsklinikum Erlangen

Anna-Jasmina Donaubauer, Dr. rer. nat.

Role: PRINCIPAL_INVESTIGATOR

Strahlenklinik Universitätsklinikum Erlangen

Locations

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Klinik für Strahlentherapie

Augsburg, Bavaria, Germany

Site Status NOT_YET_RECRUITING

Strahlenklinik Erlangen

Erlangen, Bavaria, Germany

Site Status RECRUITING

Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Munich, Bavaria, Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Claudia Schweizer, MD

Role: CONTACT

+49 9131 85 33968

Anna-Jasmina Donaubauer, Dr. rer. nat.

Role: CONTACT

Facility Contacts

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Klinik für Strahlentherapie Augsburg

Role: primary

+49 821 400-2080

Strahlenklinik Erlangen Ambulanz

Role: primary

+4991318534080

Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Role: primary

+49 (0)89 / 4400 - 73770

Other Identifiers

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ImmunBioProBrachy

Identifier Type: -

Identifier Source: org_study_id

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