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Dosimetric and radiobiologic assessment of adaptive radiotherapy by using contour based dose painting method drived from multi-parametric MRI (mpMRI) in prostate cancer patients

Protocol summary

Study aim
Dosimetric and radiobiologic assessment of treatment planning procedures DP, IMRT, 3DCRT.
Design
A randomized, clinical trial with a parallel group design of 40 patients, enrolled between September 2019 and September 2020, and followed for four month.
Settings and conduct
This study is a randomized clinical trial. The study is done on the patients with advanced prostate cancer. Processing, imaging, measuring data and treatment plannings (DP, IMRT, and 3DCRT) of the patients will be made according to specific protocols in Roshana Cancer Center.
Participants/Inclusion and exclusion criteria
The inclusion criteria : Patients with localised high-risk prostate carcinoma. Exclusion criteria : contraindications to MRI such as cardiac pacemakers.
Intervention groups
intervention group:adaptive radiotherapy by using dose painting method . control group:radiotherapy by using common method.
Main outcome variables
tumor recurrence،,tumor volume, Apparent Diffusion Coefficient(ADC)

General information

Reason for update
Acronym
dose painting
IRCT registration information
IRCT registration number: IRCT20181006041257N1
Registration date: 2019-10-23, 1398/08/01
Registration timing: retrospective

Last update: 2019-10-23, 1398/08/01
Update count: 0
Registration date
2019-10-23, 1398/08/01
Registrant information
Name
Seyedmasoud Rezaei
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3236
Email address
m_rezaei@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-04-22, 1398/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dosimetric and radiobiologic assessment of adaptive radiotherapy by using contour based dose painting method drived from multi-parametric MRI (mpMRI) in prostate cancer patients
Public title
adaptive radiotherapy in prostate cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with localised high-risk prostate carcinoma
Exclusion criteria:
previousprostatectomy general contraindications for MRI (i.e. cardiac pacemaker,metal implants )
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed by an independent trial center. If a patient meets the inclusion criteria and has provided informed consent, the physician contacts the trial center.The most common and basic method of simple randomization is flipping a coin, with two treatment groups (control versus treatment).This randomization approach is simple and easy to implement in a clinical research.Simple randomization works well for the large clinical trails (n>100) and for small to moderate clinical trials (n<100) without covariates
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 tarbiat modares University
Street address
Tarbiat Modares University, Al-Ahmad and Chamran Cross
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.MODARES.REC.1397.163

Health conditions studied

1

Description of health condition studied
prostate cancer
ICD-10 code
N42.3
ICD-10 code description
Dysplasia of prostate

Primary outcomes

1

Description
Tumor volume
Timepoint
Before treatment and four months after radiotherapy
Method of measurement
diffusion weighted Images (DWI)

2

Description
ADC
Timepoint
Before treatment and four months after radiotherapy
Method of measurement
diffusion weighted Images (DWI)

3

Description
Prostate-specific antigen (PSA)
Timepoint
Before treatment and four months after radiotherapy
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Dosimetric and radiobiologic assessment by using contour based dose painting method drived from multi-parametric MRI.
Category
Treatment - Other

2

Description
Control group: intensity-modulated radiotherapy for patients with prostate cancer
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Roshana Radiation Oncology Center (Tehran, Iran)
Full name of responsible person
Bijan Hashemi
Street address
Tarbiat Modares University, Al-Ahmad and Chamran Cross
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4131
Fax
+98 21 8800 6544
Email
bhashemi@modares.ac.ir
Web page address
https://fa.irct.ir/user/trial/34305/update/recruitment_center

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Yaghoub Fathollahi
Street address
Tarbiat Modares University, Al-Ahmad and Chamran Cross
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4131
Fax
+98 21 8800 6544
Email
fatolahi@modares.ac.ir
Web page address
https://fa.irct.ir/user/trial/34305/update/sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology
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
The University of tarbiat modares
Full name of responsible person
Bijan Hashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Tarbiat Modares University, Al-Ahmad and Chamran Cross
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4131
Fax
+98 21 8800 6544
Email
bhashemi@modares.ac.ir
Web page address
https://fa.irct.ir/user/trial/34305/update/public_queries_contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bahram Mofid
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Farahzadi Boulevard
City
Tehran
Province
Tehran
Postal code
53571-16589
Phone
+98 21 8836 7431
Fax
+98 21 8800 6544
Email
mofid429@sbmu.ac.ir
Web page address
https://fa.irct.ir/user/trial/34305/update/scientific_queries_contact

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Seyedmasoud Rezaei
Position
Phd student at medical physics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Tehran Province, Tehran, Al Ahmad Street, No. 7، Jalal
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3236
Fax
+98 21 8800 6544
Email
m_rezaei@modares.ac.ir
Web page address
https://fa.irct.ir/user/trial/34305/update/data_updater_contact

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
Imaging data and treatment planning will be reported
When the data will become available and for how long
after the publication of results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
for patients undergoing prostate cancer
From where data/document is obtainable
tarbiat modares universality
What processes are involved for a request to access data/document
Refer to Tarbiat Modarres University, Faculty of Medicine, Department of Medical Physics
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