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Completed

NCT Number: NCT00433706

Image Guided Radiation Therapy For Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Institut Gustave Roussy

Villejuif, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control position by 3DOBI before the fraction

Procedure

Standard imaging

Procedure

Primary outcomes

  1. Prostate position under the LINAC is checked by 3D OBI (mainly cone-beam imaging, CBI) performed before the fraction.

  2. 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 outcomes

  1. Rectal and bladder, acute and late toxicities (CTCAE, SOMA-LENT)

  2. Cost comparison and cost/effectiveness analysis

  3. 2 and 5 years clinical relapse free survival rates

  4. Lack of dose in the prostate in case of decreasing the CBI frequency (using the 1rst arm for testing)

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

  • National Cancer Institute, France

Registry information

Official study title

Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 12, 2007
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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