Image Guided Radiation Therapy For Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433706
• Other study ID #: CSET 1248
• Secondary ID: IGRT-P
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2007
• Last updated: December 12, 2016
• Start date: June 2007
• Est. completion date: November 2012

Study information

• Verified date: December 2016
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Control position by 3DOBI before the fraction

• Standard imaging

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate position under the LINAC is checked by 3D OBI (mainly cone-beam imaging, CBI) performed before the fraction.
Primary	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	Rectal and bladder, acute and late toxicities (CTCAE, SOMA-LENT)
Secondary	Cost comparison and cost/effectiveness analysis
Secondary	2 and 5 years clinical relapse free survival rates
Secondary	Lack of dose in the prostate in case of decreasing the CBI frequency (using the 1rst arm for testing)