Clinical trial · Observational
Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy
Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy (ImmunBioProBrachy)
NCT07131956CI-TRIAL-00097352recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
| Prostate Cancer Patients Treated by Radiotherapy | — | UNRESOLVED | — |
| Prostate Cancer Patients Who Have Brachytherapy Seed Implant | — | UNRESOLVED | — |
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Primary brachytherapy
- description
- Patients receiving sole primary brachytherapy (either LDR-BT or HDR-BT) for low or low intermediate risk prostate cancer
- label
- Salvage brachytherapy
- description
- Patients receiving sole brachytherapy (either PDR-BT or HDR-BT) for locally recurrent prostate cancer after prior irradiation with prostate in situ
Primary outcomes (1)
- measure
- Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy
- timeFrame
- 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.
- description
- 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 (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.