Prostate Cancer Early Risk Treated by Radiosurgery Clinical Trial
Official title:
Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial
To address pertinent questions regarding the utilization of stereotactic Body Radiotherapy (SBRT) to treat prostate cancer. The Florida Robotic Radiosurgery Association (FRRA) launched the first registry for prostate cancer patients treated with SBRT. The registry is designed to track surrogate treatment endpoints including prostate specific antigen (PSA), international prostate symptom score (IPSS),sexual health in men (SHIM), and visual analogue scale (VAS) scores, in addition to physical and survival data. Utilizing an independent vendor (Advertek, Inc.) experienced with the design and implementation of similar electronic registries, FRRA developed a data collection tool that staff members with a basic medical background can use to register and upload pertinent patient data, requiring no more than 20 to 30 minutes per patient. Participating patients will be monitored in follow-up for three years, with analysis and publication of the results semi-annually.
To address pertinent questions regarding the utilization of radiosurgery (SBRT) to treat
prostate cancer. The Florida Robotic Radiosurgery Association (FRRA) launched the first
registry for prostate cancer patients treated with SBRT.
The registry is designed to track surrogate treatment endpoints including PSA, IPSS, SHIM,
QOL, Karnofsky Performance Status, VAS scores, urine and bowel health, in addition to
physical and survival data. Utilizing an independent vendor (Advertek, Inc.) experienced with
the design and implementation of similar electronic registries.
FRRA developed a data collection tool that staff members with a basic medical background can
use to register and upload pertinent patient data requiring no more than 20 to 30 minutes per
patient. Participating patients will be monitored in follow-up for three years, with analysis
and publication of the results semi-annually.
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