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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04774133

Enrollment

Registered

2021-03-01

Start date

2019-02-14

Completion date

2022-01-01

Last updated

2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasm

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.

Interventions

DIAGNOSTIC_TESTBlood sample

Pazients will undergo to blood samples at predefined times

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Italy

Contacts

Primary ContactGiuseppe Sanguineti

giuseppe.sanguineti@ifo.gov.it0652666125

Backup ContactPaola Franzoso

paola.franzoso@ifo.gov.it0652666125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026