Clinical trial · Observational
Immune Profiling After HDR in Local Relapsed Prostate Cancer
Prostate Cancer Immune Profiling Before, During and After HDR-brachytherapy in Local Relapsed Prostate Cancer (PRIMUS-study)
- 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)
Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer until now fails to respond to classical IO, like PD-1 and CTLA-4 inhibitors. Radiotherapy (RT) delivered to the primary tumor impacts both tumor cells and surrounding stromal cells. Radiation damage to cancer cells exposes tumor-specific antigens leading to increased visibility to the immune system by improved priming and activation of cytotoxic T cells. RT-induced modulation of the tumor microenvironment may also facilitate the recruitment and infiltration of immune cells by increasing the expression or T-cell attracting chemokines and by increasing T-cell docking molecules on the endothelial cells like VCAM-1. The main-hypothesis is that HDR-brachytherapy will turn an immunologically "cold" (no T-cell infiltrations) prostate cancer into an immunologically "hot" (CD4 and CD8-cell infiltrations) tumor, creating leverage points for different forms of IO.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PD-L1 | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDR salvage brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Expression of PD-(L)-1 receptor
- timeFrame
- up to 28 days
- description
- Expression of PD-(L)-1 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points.
Secondary outcomes (7)
- measure
- Expression patterns of CXCL12
- timeFrame
- up to 28 days
- description
- Expression of CXCL12 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points
- measure
- Expression patterns of IL-23
- timeFrame
- up to 28 days
- description
- Expression of IL-23 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Local relapse of prostate cancer, who is candidate for a salvage HDR treatment: * Biochemical relapse (PSA increase) * Local relapse on imaging: PSMA scan, mp-MRI * Pathology proven relapse * Willing and able to comply with the study prescriptions. * 18 years or older * Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Not eligible for proposed (HDR brachytherapy) treatment: * Life expectancy \< 10 years * Distant Metastasis * Recently TURP with big urethral defect * Not able to stop anticoagulants * Flow \< 10 ml/sec • No compliance to study procedure
References
Publications (0)
Data not yet available