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Image Guided Radiation Therapy For Prostate Cancer

This study has been completed.
National Cancer Institute, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: February 8, 2007
Last updated: December 12, 2016
Last verified: December 2016
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
Procedure: Standard imaging
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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)

Enrollment: 470
Study Start Date: June 2007
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control position by 3DOBI daily Procedure: Control position by 3DOBI before the fraction
Active Comparator: Standard imaging Procedure: Standard imaging


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00433706

Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
Principal Investigator: Renaud DE CREVOISIER, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT00433706     History of Changes
Other Study ID Numbers: CSET 1248
Study First Received: February 8, 2007
Last Updated: December 12, 2016

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Prostate adenocarcinoma treated by radiotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on May 25, 2017