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Completed

NCT Number: NCT04247217

Immune Profiling After HDR in Local Relapsed Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site PD-L1 Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Maastro

Maastricht, 6229 ET, Netherlands

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDR salvage brachytherapy

Radiation

In patients receiving HDR salvage brachytherapy for locally relapsed prostate cancer serial biopsies will be performed at 4 different time points.

Other names: biopsies

Primary outcomes

  1. Expression of PD-(L)-1 receptor

    Time frame: up to 28 days

    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

  1. Expression patterns of CXCL12

    Time frame: up to 28 days

    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

  2. Expression patterns of IL-23

    Time frame: up to 28 days

    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

  3. Expression patterns of MDSC

    Time frame: up to 28 days

    Expression of MDSC receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points

  4. Changes in T cell infiltration profiles

    Time frame: up to 28 days

    Changes in T cell infiltration profiles induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points

  5. Changes in HLA class I-A expression on tumor cells

    Time frame: up to 28 days

    Changes in HLA class I-A expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points

  6. Changes in HLA class I-B expression on tumor cells

    Time frame: up to 28 days

    Changes in HLA class I-B expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points

  7. Changes in HLA class I-C expression on tumor cells

    Time frame: up to 28 days

    Changes in HLA class I-C expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Official study title

Prostate Cancer Immune Profiling Before, During and After HDR-brachytherapy in Local Relapsed Prostate Cancer (PRIMUS-study)

Acronym: PRIMUS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 29, 2020
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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