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The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04774133
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Collaborators:
Paola Nisticò
Iole Cordone
Adriana Faiella
Paola Trono
Serena Masi
Roberta Merola
Anna Antenucci
Maria Laura Foddai
Maria Consiglia Ferriero
Diana Giannarelli
Paolo Di Ridolfi
Information provided by (Responsible Party):
Giuseppe Sanguineti, Regina Elena Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Diagnostic Test: Blood sample Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.
Actual Study Start Date : February 14, 2019
Actual Primary Completion Date : February 25, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Intervention Details:
  • Diagnostic Test: Blood sample
    Pazients will undergo to blood samples at predefined times

Outcome Measures
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Primary Outcome Measures :
  1. to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg, [ Time Frame: 12 months ]
    quantitative variation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774133


Contacts
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Contact: Giuseppe Sanguineti 0652666125 giuseppe.sanguineti@ifo.gov.it
Contact: Paola Franzoso 0652666125 paola.franzoso@ifo.gov.it

Locations
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Italy
IRCSS Regina Elena Recruiting
Roma, Italy, 00144
Contact: Giuseppe Sanguineti, Head Physician       giuseppe.sanguineti@ifo.gov.it   
Sponsors and Collaborators
Regina Elena Cancer Institute
Paola Nisticò
Iole Cordone
Adriana Faiella
Paola Trono
Serena Masi
Roberta Merola
Anna Antenucci
Maria Laura Foddai
Maria Consiglia Ferriero
Diana Giannarelli
Paolo Di Ridolfi
Investigators
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Principal Investigator: Giuseppe Sanguineti IFO
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Giuseppe Sanguineti, Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer., Regina Elena Cancer Institute
ClinicalTrials.gov Identifier: NCT04774133    
Other Study ID Numbers: 1163/18
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases