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Image Guided Radiation Therapy For Prostate Cancer

Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00433706
Enrollment
470
Registered
2007-02-12
Start date
2007-06-30
Completion date
2012-11-30
Last updated
2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate adenocarcinoma treated by radiotherapy

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.

Interventions

PROCEDUREControl position by 3DOBI before the fraction

Sponsors

National Cancer Institute, France
CollaboratorOTHER_GOV
Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
MALE
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026