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Clinical Trial Summary

This prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. Subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. Hypothesis: 1. Treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced PTV margin will result in a significant decrease in rectal and bladder volume treated.


Clinical Trial Description

This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including:

- decreased acute and chronic adverse effects with similar local tumor control

- dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment

- hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01589939
Study type Observational
Source U.S. Army Medical Research Acquisition Activity
Contact
Status Active, not recruiting
Phase N/A
Start date March 2009
Completion date August 2016

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