NCT04774133

The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DIAGNOSTIC_TEST	Blood sample	Pazients will undergo to blood samples at predefined times

Timeline

• Start date: 2019-02-14
• Primary completion: 2021-02-25
• Completion: 2022-01-01
• First posted: 2021-03-01
• Last updated: 2021-03-01

Locations

1 site across 1 country: Italy