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

NCT ID: NCT02279693

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-22

Study Completion Date

2019-08-06

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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CBCT

cone beam computed tomography (CBCT) repositioning

Group Type OTHER

CBCT

Intervention Type OTHER

10 participants will receive a cone beam computed tomography (CBCT) repositioning

IGRT Associated With IMRT

Intervention Type RADIATION

fiducial markers

kV imaging of fiducial marker repositioning

Group Type OTHER

fiducial marker (kV imaging)

Intervention Type OTHER

10 participants will receive a kV imaging of fiducial marker repositioning.

IGRT Associated With IMRT

Intervention Type RADIATION

Interventions

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CBCT

10 participants will receive a cone beam computed tomography (CBCT) repositioning

Intervention Type OTHER

fiducial marker (kV imaging)

10 participants will receive a kV imaging of fiducial marker repositioning.

Intervention Type OTHER

IGRT Associated With IMRT

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Georges Francois Leclerc

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles CREHANGE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Georges François Leclerc

Locations

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Centre Georges-François Leclerc

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00122-45

Identifier Type: -

Identifier Source: org_study_id

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