The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.
Primary Purpose
Prostatic Neoplasm
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasm
Eligibility 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
Sites / Locations
- IRCSS Regina ElenaRecruiting
Outcomes
Primary Outcome Measures
to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,
quantitative variation
Secondary Outcome Measures
Full Information
NCT ID
NCT04774133
First Posted
February 23, 2021
Last Updated
February 25, 2021
Sponsor
Regina Elena Cancer Institute
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
1. Study Identification
Unique Protocol Identification Number
NCT04774133
Brief Title
The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.
Official Title
Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regina Elena Cancer Institute
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
Pazients will undergo to blood samples at predefined times
Primary Outcome Measure Information:
Title
to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,
Description
quantitative variation
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Sanguineti
Phone
0652666125
Email
giuseppe.sanguineti@ifo.gov.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Franzoso
Phone
0652666125
Email
paola.franzoso@ifo.gov.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Sanguineti
Organizational Affiliation
IFO
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCSS Regina Elena
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Sanguineti, Head Physician
Email
giuseppe.sanguineti@ifo.gov.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.
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