Image Guided Radiation Therapy For Prostate Cancer

This study is currently recruiting participants.

Verified by Institut Gustave Roussy, September 2007

First Received: February 8, 2007 Last Updated: September 11, 2007 History of Changes

Sponsor:	Institut Gustave Roussy
Collaborator:	National Cancer Institute, France
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00433706

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Procedure: Control position by 3DOBI before the fraction	Phase III

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome 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 Outcome 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)

Estimated Enrollment:	520
Study Start Date:	June 2007
Estimated Study Completion Date:	September 2007

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433706

Contacts

Contact: Renaud DE CREVOISIER, MD

00 33 1 42 11 45 66

renaud.de.crevoisier@igr.fr

Locations

France
Institut Gustave Roussy	Recruiting
VILLEJUIF, France, 94805
Contact: Renaud DE CREVOISIER, MD 00 33 142 11 45 66 renaud.de.crevoisier@igr.fr

Sponsors and Collaborators

Institut Gustave Roussy

National Cancer Institute, France

Investigators

Principal Investigator:

Renaud DE CREVOISIER, MD

Institut Gustave Roussy

More Information

No publications provided

Study ID Numbers:	CSET 1248, IGRT-P
Study First Received:	February 8, 2007
Last Updated:	September 11, 2007
ClinicalTrials.gov Identifier:	NCT00433706 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:

Prostate adenocarcinoma treated by radiotherapy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010