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NCT04774133 Clinical Trial

The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.

Prostatic Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04774133
Other study ID # 1163/18
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 14, 2019
Est. completion date January 1, 2022

Study information
Verified date February 2021
Source Regina Elena Cancer Institute
Contact Giuseppe Sanguineti
Phone 0652666125
Email giuseppe.sanguineti@ifo.gov.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 1, 2022
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood sample
Pazients will undergo to blood samples at predefined times

Locations
Country Name City State
Italy IRCSS Regina Elena Roma

Sponsors (12)
Lead Sponsor Collaborator
Regina Elena Cancer Institute Adriana Faiella, Anna Antenucci, Diana Giannarelli, Iole Cordone, Maria Consiglia Ferriero, Maria Laura Foddai, Paola Nisticò, Paola Trono, Paolo Di Ridolfi, Roberta Merola, Serena Masi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg, quantitative variation 12 months
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