Skip to main content
Clinical Trials/NCT04774133
NCT04774133
Unknown
Not Applicable

Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.

Regina Elena Cancer Institute1 site in 1 country50 target enrollmentFebruary 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostatic Neoplasm
Sponsor
Regina Elena Cancer Institute
Enrollment
50
Locations
1
Primary Endpoint
to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,
Last Updated
5 years ago

Overview

Brief Summary

Radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. Several studies demonstrated a significant reduction of lymphocytes during RT but there are only a few studies monitoring these cells in the treatment of prostate cancer. This study will enroll 50 patients with hystologically proven prostate cancer who will undergo to radiotherapy according to Institutional protocols.

This study aims to evaluate the effect of RT on immuno-regulatory B, NK, T, B and T lymphocyte subpopulations (Breg and Treg) and plasma cells, quantitative / qualitative changes,their correlations with the clinical course of the disease and acute and late toxicity. In parallel, using multicolor panels (12 colors) we will evaluate the expression of inhibitory checkpoints and TGFβ signaling.

The final objective is to identify new therapeutic targets to be combined with RT.

Registry
clinicaltrials.gov
Start Date
February 14, 2019
End Date
January 1, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Giuseppe Sanguineti

Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.

Regina Elena Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • Histologically documented prostatic cancer
  • Indication to perform radiotherapy treatment
  • Age over 18 years
  • Informed consent

Exclusion Criteria

  • Hematological diseases
  • Autoimmune diseases
  • Previous neoplasias
  • Prior chemotherapy or other therapies that may have violated the hematopoietic organs
  • Patient's refusal to undergo periodic blood samples

Outcomes

Primary Outcomes

to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,

Time Frame: 12 months

quantitative variation

Study Sites (1)

Loading locations...

Similar Trials