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

  • France
      • 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
Other: CBCT
10 participants will receive a cone beam computed tomography (CBCT) repositioning
Radiation: IGRT Associated With IMRT
Other: fiducial markers
kV imaging of fiducial marker repositioning
Radiation: IGRT Associated With IMRT
Other: fiducial marker (kV imaging)
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

Centre Georges Francois Leclerc

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

Keywords

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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