The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.

NCT04774133 | Unknown

• 1 other identifier: 1163/18
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,

  quantitative variation

  12 months

Interventions

Blood sample DIAGNOSTIC_TEST

Pazients will undergo to blood samples at predefined times

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented prostatic cancer
• Indication to perform radiotherapy treatment
• Age over 18 years
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Paola Nisticò: collaborator
• Iole Cordone: collaborator
• Adriana Faiella: collaborator
• Paola Trono: collaborator
• Serena Masi: collaborator
• Roberta Merola: collaborator
• Anna Antenucci: collaborator
• Maria Laura Foddai: collaborator
• Maria Consiglia Ferriero: collaborator
• Diana Giannarelli: collaborator
• Paolo Di Ridolfi: collaborator

Study Sites (1)

IRCSS Regina Elena

Roma, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Giuseppe Sanguineti

  IFO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Sanguineti

CONTACT

0652666125; giuseppe.sanguineti@ifo.gov.it

Paola Franzoso

CONTACT

0652666125; paola.franzoso@ifo.gov.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 1, 2021
• Study Start: February 14, 2019
• Primary Completion: February 25, 2021
• Study Completion: January 1, 2022
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

IT (1)