Immune Profiling After HDR in Local Relapsed Prostate Cancer

NCT04247217 | Completed

• 1 other identifier: PRIMUS
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; PD-L1

Outcome Measures

Primary Outcomes (1)

• Expression of PD-(L)-1 receptor

  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.

  up to 28 days

Secondary Outcomes (7)

• Expression patterns of CXCL12

  up to 28 days

• Expression patterns of IL-23

  up to 28 days

• Expression patterns of MDSC

  up to 28 days

• Changes in T cell infiltration profiles

  up to 28 days

• Changes in HLA class I-A expression on tumor cells

  up to 28 days

Interventions

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.

Also known as: biopsies

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: prostate tumor biopsies
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with local relapse of prostate cancer, who are candidate for a salvage HDR treatment will be asked to participate in this study at the time of intake.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastro

Maastricht, 6229 ET, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

In patients receiving HDR salvage brachytherapy for locally relapsed prostate cancer serial biopsies will be performed at 4 different time points. Furthermore, peripheral blood samples during anesthesia will be collected.

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ben Vanneste, MD, PhD

  Maastro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 29, 2020
• Study Start: February 19, 2020
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)