Comparison of serum profile of inflammatory cytokines in high or unfavorable intermediate-risk localized prostate cancer patients treated with definitive whole pelvis radiation therapy plus external beam boost versus high dose rate brachytherapy boost.
Boost with interstitial brachytherapy with high dose rate compared to boost with conformal three-dimensional radiotherapy technique, stimulates the patient's immune system against prostate cancer with a different mechanism, and this may lead to improved treatment outcomes in these patients. Be
Design
The clinical trial consisted of two parallel not blind groups and
Randomization is done by envelope method on 20 patients
Settings and conduct
20 patients with moderate (undesirable) and high risk local prostate cancer who were referred to the clinical oncology ward of Golestan Hospital in Ahvaz in 1400 and are candidates for radiotherapy only in addition to neo-adjuvant hormone therapy (2 months), simultaneous and adjuvant (minimum). 3 months), will enter the study. After completion of full pelvic radiotherapy, patients will be randomly divided into two groups: external radiotherapy boost and interstitial brachytherapy with high dose rate. Serum levels of inflammatory cytokines, including interleukin-6, interleukin-8, and TNF-alpha, will be measured in all patients two weeks before the start of radiotherapy, and one and three months after the end of radiotherapy
Participants/Inclusion and exclusion criteria
1) Age ≥ 18 years
2) Eastern Cooperative Oncology Group (ECOG) Performance scale zero or one
3) Localized prostate adenocarcinoma confirmed by pathology with moderate (Unfavorable) and high risk according to National Comprehensive Cancer Network (NCCN) criteria (first version 2021)
Intervention groups
In group A, the effect of external radiotherapy and in group B, the effect of brachytherapy on the patient's immune system are evaluated.
Main outcome variables
Serum levels of inflammatory cytokines including interleukin-6, interleukin-8 and TNF-alpha will be measured
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211004052674N1
Registration date:2021-12-11, 1400/09/20
Registration timing:registered_while_recruiting
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Iman Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
dr.iman1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of serum profile of inflammatory cytokines in high or unfavorable intermediate-risk localized prostate cancer patients treated with definitive whole pelvis radiation therapy plus external beam boost versus high dose rate brachytherapy boost.
Public title
Comparison of serum profile of inflammatory cytokines in localized prostate cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18 year
Eastern Cooperative Oncology Group (ECOG) performance zero or one
Localized prostate adenocarcinoma confirmed by pathology with moderate (Unfavorable) and high risk according to National Comprehensive Cancer Network criteria(NCCN) (first edition 2021)
Exclusion criteria:
Severe physical illness or mental disorder that, according to the researcher, prevents treatment according to the protocol
Patients who cannot be followed up regularly
Contraindications for external radiotherapy or brachytherapy
Previous history of external radiotherapy or prostate brachytherapy
History of any prostate surgery
Any history of malignancy (except for non-melanoma skin cancers)
History of Chemotherapy, Targeted Therapy and the use of immunosuppressive drugs
History of chronic infectious diseases (HIV, viral hepatitis, etc.)
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with a sealed envelope
Twenty letters are used in the form of ten group A numbers and ten group B numbers
People in group A will only receive external beam radiotherapy, and people in group B will be treated with brachytherapy
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University
Street address
Golestan hospital, Farvardin street
City
ahvaz
Province
Khouzestan
Postal code
3311861357
Approval date
2021-11-05, 1400/08/14
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.099
Health conditions studied
1
Description of health condition studied
Prostate Cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum profile of inflammatory cytokines
Timepoint
Serum levels of inflammatory cytokines are measured two weeks before the start of radiotherapy, and one and three months after the end of radiotherapy.
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This group undergoes external radiotherapy. Before the start of treatment and after one month and three months after the end of external radiotherapy, the level of inflammatory cytokines of interleukin 6, interleukin 8 and TNF alpha are evaluated
Category
Treatment - Devices
2
Description
Intervention group: In addition to external radiotherapy, this group undergoes brachytherapy. Before the start of treatment and one month and then three months after the end of treatment, inflammatory levels of interleukin 6, interleukin 8 and TNF alpha are evaluated
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Ali Bagheri
Street address
Golestan hospital, Farvardin street
City
Ahvaz
Province
Khouzestan
Postal code
3311861357
Phone
+98 61 3374 3001
Email
dr.iman1369@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali bagheri
Street address
Golestan hospital, Farvardin street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2206
Email
Ahvaz.Eleaning@mail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali bagheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Golestan hospital, Farvardin street
City
Ahvaz
Province
Khouzestan
Postal code
3311861357
Phone
+98 61 3374 3001
Email
alibagheri.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali bagheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Golestan hospital, Farvardin street
City
Ahvaz
Province
Khouzestan
Postal code
3311861357
Phone
+98 61 3374 3001
Email
alibagheri.md@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali bagheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Golestan hospital, Farvardin street
City
Ahvaz
Province
Khouzestan
Postal code
3311861357
Phone
+98 61 3374 3001
Email
alibagheri.md@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome or the like can be shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Academic and scientific community
Under which criteria data/document could be used
Use in clinical studies
From where data/document is obtainable
Ahvaz Jundishapur University
What processes are involved for a request to access data/document