Image Guided Radiation Therapy For Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Control position by 3DOBI before the fraction; Procedure: Standard imaging

• Registration Number: NCT00433706
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-08
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-12
• Study Start: 2007-06
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 470

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control position by 3DOBI daily	Control position by 3DOBI before the fraction	-
Standard imaging	Standard imaging	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rectal and bladder, acute and late toxicities (CTCAE, SOMA-LENT)
Cost comparison and cost/effectiveness analysis
Lack of dose in the prostate in case of decreasing the CBI frequency (using the 1rst arm for testing)
2 and 5 years clinical relapse free survival rates

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France