Trans-Rectal Ultrasound-Guided (TRUS) Adverse Events
The goal of this study is to identify any side effects caused by the implanting of markers via the rectum. The investigators will also try to determine if any other factors (such as the position of the markers) influence the risk of side effects. The study procedures consist of two questionnaires:The first will be completed immediately after the marker implantation and the second questionnaire will be completed during your radiotherapy planning.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Quantification of Patient-Reported Adverse Events Following Trans-Rectal Ultrasound-Guided Intra-Prostatic Marker Insertion|
- Quantify adverse events reported by prostate patients following trans-rectal ultrasound-guided implantation of intra-prostatic markers for RT [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Precise localisation of target organs has become increasingly important with the routine use of steep dose gradients from conformal and intensity modulated radiotherapy. This is particularly challenging when soft tissue target organs, such as the prostate, displace relative to bony anatomy. Although novel imaging techniques are being developed for the direct visualisation of such soft tissue structures, contrast and image quality is currently limited. However, the use of radio-opaque intra-prostatic fiducial markers(IPM) during high dose radiotherapy has proven very effective in terms of improving accuracy, and decreasing toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923416
|University Health Network, Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Tara Rosewall||University Health Network, Princess Margaret Hospital|