The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.
NCT04774133 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-03-01
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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