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Recruiting NCT07131956

Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prostate Cancer (Diagnosis), Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer Recurrent. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • Treatment-related toxicity [Time frame: Up to 6 months]
  • recurrence-free survival [Time frame: Up to 6 months]
  • Overall survival [Time frame: Up to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 3 centers
  • Klinik für Strahlentherapie — Augsburg
  • Strahlenklinik Erlangen — Erlangen
  • Klinik und Poliklinik für Strahlentherapie und Radioonkologie — Munich

Identifiers

NCT: NCT07131956 · ImmunBioProBrachy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗