Immune Profiling After HDR in Local Relapsed Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    10
  • sponsor
    Maastricht Radiation Oncology
Updated on 3 March 2021
tumor cells
brachytherapy
multiparametric magnetic resonance imaging

Summary

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.

Description

Prospective analysis of biopsies from 10 patients with local recurrence in the prostate selected for salvage HDR brachytherapy in MAASTRO Clinic, Maastricht. HDR treatment is standard in Maastro Clinic for local relapses of prostate cancer after previously irradiation (internal or external).

Biopsies will be taken at 4 different time points (before and after the 1st fraction; before the 2nd and 3rd fraction of the salvage treatment).

Several immunotyping (expression of PD-(L)-1, CXCL12, IL-23 receptor, etc.) and HLA class I expression will be performed on the biopsies. In addition, HLA genotypes will be determined on DNA isolated from pheripheral blood.

The plasma and the biopsies will be stored for eventually additional research.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, PD-L1, prostate carcinoma, prostate cancers, PD-L1, PD-L1, PD-L1, PD-L1, PD-L1
Treatment HDR salvage brachytherapy
Clinical Study IdentifierNCT04247217
SponsorMaastricht Radiation Oncology
Last Modified on3 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or PD-L1 or Prostatic disorder or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate?
Do you have any of these conditions: Prostate Disorders or prostate carcinoma or Prostatic disorder or Malignant neoplasm of prostate or Prostate Cancer, Early, Recurrent or Prostate Canc...?
Do you have any of these conditions: Prostate Disorders or Prostate Cancer or prostate carcinoma or Prostate Cancer, Early, Recurrent or prostate cancers or Malignant neoplasm of prostate...?
Do you have any of these conditions: Prostatic disorder or PD-L1 or Prostate Cancer or Prostate Disorders or Malignant neoplasm of prostate or prostate cancers or prostate carcinoma or Pr...?
Do you have any of these conditions: prostate cancers or PD-L1 or Malignant neoplasm of prostate or Prostate Cancer, Early, Recurrent or Prostatic disorder or prostate carcinoma or Prosta...?
Do you have any of these conditions: prostate carcinoma or prostate cancers or Prostate Cancer or PD-L1 or Malignant neoplasm of prostate or Prostatic disorder or Prostate Cancer, Early, ...?
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
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
Clear my responses

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