The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.

NCT04774133 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-03-01

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasm

Interventions

DIAGNOSTIC_TEST

Blood sample

Pazients will undergo to blood samples at predefined times

Sponsors & Collaborators

  • Paola Nisticò

    collaborator UNKNOWN
  • Iole Cordone

    collaborator UNKNOWN
  • Adriana Faiella

    collaborator UNKNOWN
  • Paola Trono

    collaborator UNKNOWN
  • Serena Masi

    collaborator UNKNOWN
  • Roberta Merola

    collaborator UNKNOWN
  • Anna Antenucci

    collaborator UNKNOWN
  • Maria Laura Foddai

    collaborator UNKNOWN
  • Maria Consiglia Ferriero

    collaborator UNKNOWN
  • Diana Giannarelli

    collaborator UNKNOWN
  • Paolo Di Ridolfi

    collaborator UNKNOWN
  • Regina Elena Cancer Institute

    lead OTHER

Principal Investigators

  • Giuseppe Sanguineti · IFO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2021-02-25
Completion
2022-01-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04774133 on ClinicalTrials.gov