Multi-Institutional Registry for Prostate Cancer Radiosurgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial

Conditions
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Prostate Cancer Early Risk Treated by Radiosurgery, Prostate Cancer Intermediate Risk Treated by Radiosurgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathological diagnosis of prostate cancer early or intermediate risk Exclusion Criteria: high risk prostate cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Outcomes | Measurement of surrogate outcomes including IPSS and SHIM scores | 5 years | 
| Treatment toxicity | urinary and rectal complications as well as sexual health | 5 years | 
| Assess biochemical disease free survival using PSA |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiosurgery, prostate, cancer, early, intermediate, CyberKnife