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...
Date First Received: February 8, 2007
Last Updated: September 11, 2007
Verified by: Institut Gustave Roussy, September 2007
Clinical Trial Phase: Phase 3 | Start Date: June 2007
Overall Status: Recruiting
Estimated Enrollment: 520
Brief Summary
Official Title: “Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Procedure: Control position by 3DOBI before the fraction
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- 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)
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Institut Gustave Roussy
Overall Clinical Trial Officials and Contacts
Renaud DE CREVOISIER, MD Principal Investigator Institut Gustave Roussy
Overall Contact: Renaud DE CREVOISIER, MD 00 33 1 42 11 45 66 renaud.de.crevoisier@igr.fr
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00433706
Study ID Number: CSET 1248
ClinicalTrials.gov Identifier: NCT00433706
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
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