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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer|
- 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 ] [ Designated as safety issue: Yes ]
- International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Successful implantation of the Blip in the prostate [ Time Frame: 1 wk ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Performance of the RTPS in at least five of approximately 40 radiation therapy sessions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Record target volume movement during at least 5 radiation therapy sessions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921193
|Leuven, Belgium, B - 3000|
|Dr. Bernard Verbeeten Institute|
|Principal Investigator:||Philip MP Poortmans, MD, PhD||Dr. Bernard Verbeeten Instituut|
|Principal Investigator:||Willy JM de Kruijf, PhD||Dr. Bernard Verbeeten Instituut|
|Principal Investigator:||Karin Haustermans, MD||leuvens kankerinstituut|