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

Prostate Cancer Clinical Trial

— PROSTRACK  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02279693
• Other study ID #: 2014-A00122-45
• Status: Terminated
• Phase: N/A
• Start date: December 22, 2014
• Est. completion date: August 6, 2019

Study information

• Verified date: February 2024
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 6, 2019
• Est. primary completion date: December 22, 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• CBCT
10 participants will receive a cone beam computed tomography (CBCT) repositioning
• fiducial marker (kV imaging)
10 participants will receive a kV imaging of fiducial marker repositioning.

Radiation:
• IGRT Associated With IMRT

Locations

Country	Name	City	State
France	Centre Georges-François Leclerc	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)		8 weeks