Prostate Cancer Clinical Trial
Official title:
Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer
The study aims to evaluate the safety and performance of the RTPS in patients with localized prostate cancer.The RTPS is an investigational device and requires permanent implantation of a small radioactive fiducial, called the Blip, in the prostate.
The high precision of planned radiotherapy treatments requires accurate positioning of the
prostate in order to ensure that the tightly conformed dose distribution does not miss the
prostate and result in either significant tumor underdosage, an increased dose to the rectum
or bladder, or both. Precise delivery has been addressed using a variety of pre-treatment
localization systems. The most direct localization of the prostate involves the use of
ultrasound, computed tomography (CT), or radiography of permanently implanted fiducial
markers.
In this study the safety and performance of a novel investigational tracking system will be
evaluated. The Radiation Therapy Positioning System (RTPS) is a radioactive tracking system
integrated into the radiotherapy set-up workflow. The System is composed of the Clinical
Positioning System (CPS) and a radioactive soft tissue implanted fiducial (Blip), which is
permanently implanted in the prostate. By tracking the implanted Blip, the CPS can monitor
positional changes prior to and during the treatment.
The accuracy of the RTPS localization will be compared to the CBCT in at least 5 radiation
therapy sessions per patient.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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