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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Leuvens Kankerinstituut
Leuven, Belgium
Dr. Bernard Verbeeten Institute
Tilburg, Netherlands
Device related adverse events by evaluation of the type, frequency and severity of the device, implantation device and/or implantation procedure related adverse events
Time frame: 6 months
International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy.
Time frame: 3 weeks
Successful implantation of the Blip in the prostate
Time frame: 1 wk
Non migration of the Blip as evaluated by measuring the average absolute change in inter-marker distances measured during and at the end of radiotherapy treatment
Time frame: 10 weeks
Performance of the RTPS in at least five of approximately 40 radiation therapy sessions
Time frame: 8 weeks
Record target volume movement during at least 5 radiation therapy sessions
Time frame: 8 weeks
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