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Clinical Trials/NCT02279693
NCT02279693TerminatedNot Applicable

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

Centre Georges Francois Leclerc1 site in 1 country3 target enrollmentStarted: December 22, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
3
Locations
1
Primary Endpoint
dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •male > 18 years
  • •carcinoma of the prostate histologically confirmed
  • •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

Arms & Interventions

CBCT

Other

cone beam computed tomography (CBCT) repositioning

Intervention: CBCT (Other)

CBCT

Other

cone beam computed tomography (CBCT) repositioning

Intervention: IGRT Associated With IMRT (Radiation)

fiducial markers

Other

kV imaging of fiducial marker repositioning

Intervention: fiducial marker (kV imaging) (Other)

fiducial markers

Other

kV imaging of fiducial marker repositioning

Intervention: IGRT Associated With IMRT (Radiation)

Outcomes

Primary Outcomes

dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)

Time Frame: 8 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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