- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02279693
Evaluation of the Dose Received by the Prostate With in Vivo Dosimetry in Patients Treated With Daily IGRT Associated With IMRT Using Two Repositioning Techniques for Localized Prostate Cancer (PROSTRACK)
February 12, 2024 updated by: Centre Georges Francois Leclerc
This study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
10 participants will receive a cone beam computed tomography (CBCT) repositioning, while the other 10 will receive a kV imaging of fiducial marker repositioning.
The principal objective is to evaluate and compare the dose received by the prostate using two repositioning techniques.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dijon, France, 21000
- Centre Georges-François Leclerc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- male > 18 years
- carcinoma of the prostate histologically confirmed
- OMS 0-1
- localized stage
- favorable, intermediate and unfavorable groups according to NCCN or D'Amico classification
- patients must have signed a written informed consent form
- patients must be affiliated to a Social Health Insurance.
Exclusion Criteria:
- metastasis
- indication for pelvic radiation
- anticoagulant therapy
- lateral or bilateral hip replacement
- patient receiving an adult protective services
- Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: CBCT
cone beam computed tomography (CBCT) repositioning
|
10 participants will receive a cone beam computed tomography (CBCT) repositioning
|
Other: fiducial markers
kV imaging of fiducial marker repositioning
|
10 participants will receive a kV imaging of fiducial marker repositioning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gilles CREHANGE, MD, PhD, Centre Georges François Leclerc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2014
Primary Completion (Actual)
December 22, 2014
Study Completion (Actual)
August 6, 2019
Study Registration Dates
First Submitted
October 28, 2014
First Submitted That Met QC Criteria
October 30, 2014
First Posted (Estimated)
October 31, 2014
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A00122-45
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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