Back to resultsEvaluation 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)
Primary Purpose
Prostate Cancer
Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CBCT
fiducial marker (kV imaging)
IGRT Associated With IMRT
Sponsored by
About this trial
This is an interventional health services research trial for Prostate Cancer focused on measuring Raypilot dosimetry, CBCT (cone beam computed tomography)
Eligibility Criteria
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
Sites / Locations
- Centre Georges-François Leclerc
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
CBCT
fiducial markers
Arm Description
cone beam computed tomography (CBCT) repositioning
kV imaging of fiducial marker repositioning
Outcomes
Primary Outcome Measures
dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)
Secondary Outcome Measures
Full Information
NCT ID
NCT02279693
First Posted
October 28, 2014
Last Updated
October 25, 2019
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT02279693
Brief Title
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
Acronym
PROSTRACK
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Suspended
Study Start Date
December 22, 2014 (Actual)
Primary Completion Date
December 22, 2014 (Actual)
Study Completion Date
January 21, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Raypilot dosimetry, CBCT (cone beam computed tomography)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBCT
Arm Type
Other
Arm Description
cone beam computed tomography (CBCT) repositioning
Arm Title
fiducial markers
Arm Type
Other
Arm Description
kV imaging of fiducial marker repositioning
Intervention Type
Other
Intervention Name(s)
CBCT
Intervention Description
10 participants will receive a cone beam computed tomography (CBCT) repositioning
Intervention Type
Other
Intervention Name(s)
fiducial marker (kV imaging)
Intervention Description
10 participants will receive a kV imaging of fiducial marker repositioning.
Intervention Type
Radiation
Intervention Name(s)
IGRT Associated With IMRT
Primary Outcome Measure Information:
Title
dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles CREHANGE, MD, PhD
Organizational Affiliation
Centre Georges François Leclerc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges-François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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