Image Guided Radiation Therapy For Prostate Cancer
Information source: Institut Gustave Roussy
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Control position by 3DOBI before the fraction (Procedure)
Phase: Phase 3
Status: Recruiting
Sponsored by: Institut Gustave Roussy Official(s) and/or principal investigator(s):
Renaud DE CREVOISIER, MD, Principal Investigator, Affiliation: Institut Gustave Roussy
Overall contact:
Renaud DE CREVOISIER, MD, Phone: 00 33 1 42 11 45 66, Email: renaud.de.crevoisier@igr.fr
Summary
During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has
an intra-pelvic motion which is not detectable by the conventional portal imaging. This
prostate motion may lead to a mistargeting, which possibly decreases the local control. On
the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is
expensive. The cost/effectiveness ratio is not well established, as well as the frequency of
using such imaging during the course of radiation.
Clinical Details
Official title: Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer
Study design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Prostate position under the LINAC is checked by 3D OBI (mainly cone-beam imaging, CBI) performed before the fraction.To validate the optimal strategy of IGRT for prostate adenocarcinoma based on 2 and 5 year-disease free survival rates (events= biochemical failure or death).
Secondary outcome: Rectal and bladder, acute and late toxicities (CTCAE, SOMA-LENT)Cost comparison and cost/effectiveness analysis 2 and 5 years clinical relapse free survival rates Lack of dose in the prostate in case of decreasing the CBI frequency (using the 1rst arm for testing)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- prostate adenocarcinoma
- intermediate / high risk group
- N0 or N -
- treatment by conformal radiotherapy (including or not IMRT), with or without androgen
deprivation
Exclusion Criteria:
- pelvic irradiation
- metal objects in the pelvis
Locations and Contacts
Renaud DE CREVOISIER, MD, Phone: 00 33 1 42 11 45 66, Email: renaud.de.crevoisier@igr.fr
Institut Gustave Roussy, VILLEJUIF 94805, France; Recruiting
Renaud DE CREVOISIER, MD, Phone: 00 33 142 11 45 66, Email: renaud.de.crevoisier@igr.fr
Additional Information
Starting date: June 2007
Ending date: September 2007
Last updated: September 11, 2007
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