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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)

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ClinicalTrials.gov Identifier: NCT02279693
Recruitment Status : Suspended
First Posted : October 31, 2014
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: CBCT Other: fiducial marker (kV imaging) Radiation: IGRT Associated With IMRT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Actual Study Start Date : December 22, 2014
Actual Primary Completion Date : December 22, 2014
Estimated Study Completion Date : January 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
CBCT
cone beam computed tomography (CBCT) repositioning
Other: CBCT
10 participants will receive a cone beam computed tomography (CBCT) repositioning

Radiation: IGRT Associated With IMRT
fiducial markers
kV imaging of fiducial marker repositioning
Other: fiducial marker (kV imaging)
10 participants will receive a kV imaging of fiducial marker repositioning.

Radiation: IGRT Associated With IMRT



Primary Outcome Measures :
  1. dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation) [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279693


Locations
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France
Centre Georges-François Leclerc
Dijon, France, 21000
Sponsors and Collaborators
Centre Georges Francois Leclerc
Investigators
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Principal Investigator: Gilles CREHANGE, MD, PhD Centre Georges-François Leclerc

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Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT02279693    
Other Study ID Numbers: 2014-A00122-45
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Keywords provided by Centre Georges Francois Leclerc:
Raypilot dosimetry
CBCT (cone beam computed tomography)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases