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

NCT02279693 | Terminated

• 1 other identifier: 2014-A00122-45
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Raypilot dosimetry; CBCT (cone beam computed tomography)

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Study Arms (2)

CBCT

OTHER

cone beam computed tomography (CBCT) repositioning

Other: CBCT; Radiation: IGRT Associated With IMRT

fiducial markers

OTHER

kV imaging of fiducial marker repositioning

Other: fiducial marker (kV imaging); Radiation: IGRT Associated With IMRT

Interventions

CBCT OTHER

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

CBCT

fiducial marker (kV imaging) OTHER

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

fiducial markers

IGRT Associated With IMRT RADIATION

CBCT; fiducial markers

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges-François Leclerc

Dijon, 21000, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fiducial Markers; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reference Standards; Weights and Measures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies; Radiation Equipment and Supplies; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Gilles CREHANGE, MD, PhD

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 31, 2014
• Study Start: December 22, 2014
• Primary Completion: December 22, 2014
• Study Completion: August 6, 2019
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

FR (1)