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

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Other: CBCT; Other: fiducial marker (kV imaging); Radiation: IGRT Associated With IMRT

• Registration Number: NCT02279693
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-10-31
• Study Start: 2014-12-22
• Primary Completion: 2014-12-22
• Study Completion: 2019-08-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBCT	CBCT	cone beam computed tomography (CBCT) repositioning
CBCT	IGRT Associated With IMRT	cone beam computed tomography (CBCT) repositioning
fiducial markers	fiducial marker (kV imaging)	kV imaging of fiducial marker repositioning
fiducial markers	IGRT Associated With IMRT	kV imaging of fiducial marker repositioning

Primary Outcome Measures

Name	Time	Method
dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)	8 weeks

Trial Locations

Locations (1)

Centre Georges-François Leclerc; 🇫🇷 Dijon, France