Multi-Institutional Registry for Prostate Cancer Radiosurgery
- Conditions
- Prostate Cancer Early Risk Treated by RadiosurgeryProstate Cancer Intermediate Risk Treated by Radiosurgery
- Registration Number
- NCT01226004
- Lead Sponsor
- RPCR, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 3000
- pathological diagnosis of prostate cancer
- early or intermediate risk
- high risk prostate cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival 5 years
- Secondary Outcome Measures
Name Time Method Treatment Outcomes 5 years Measurement of surrogate outcomes including IPSS and SHIM scores
Treatment toxicity 5 years urinary and rectal complications as well as sexual health
Assess biochemical disease free survival using PSA 5 years
Trial Locations
- Locations (44)
Memorial Cancer Institute CyberKnife Center
🇺🇸Pembroke Pines, Florida, United States
CyberKnife Center of South Florida in Stuart
🇺🇸Stuart, Florida, United States
Naples Radiation Oncology
🇺🇸Naples, Florida, United States
Montana Cancer Institute Foundation
🇺🇸Missoula, Montana, United States
Saint Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
CyberKnife Centers of Tampa Bay
🇺🇸Tampa, Florida, United States
Benefis Sletten Cancer Institute
🇺🇸Great Falls, Montana, United States
St. Elizabeth CyberKnife Center
🇺🇸Lincoln, Nebraska, United States
CyberKnife Center of Miami
🇺🇸Miami, Florida, United States
Cancer Treatment Centers of America
🇺🇸Tulsa, Oklahoma, United States
University of South Alabama-USA Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
CyberKnife of Birmingham
🇺🇸Birmingham, Alabama, United States
California Cancer Care
🇺🇸Fresno, California, United States
Newport Diagnostic Center
🇺🇸Newport Beach, California, United States
Skyline Radiation Oncology
🇺🇸Tustin, California, United States
Anova Cancer Care
🇺🇸Lone Tree, Colorado, United States
Illinois Cyberknife
🇺🇸Park Ridge, Illinois, United States
CyberKnife Center of Chicago
🇺🇸Elmhurst, Illinois, United States
WellStar Research Insititute
🇺🇸Marietta, Georgia, United States
Las Vegas CyberKnife
🇺🇸Henderson, Nevada, United States
United Health Services
🇺🇸Johnson City, New York, United States
Reno CyberKnife
🇺🇸Reno, Nevada, United States
First Dayton Cancer Care
🇺🇸Kettering, Ohio, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
St. John Medical Center
🇺🇸Tulsa, Oklahoma, United States
Oklahoma CyberKnife
🇺🇸Tulsa, Oklahoma, United States
Philadelphia CyberKnife
🇺🇸Havertown, Pennsylvania, United States
Austin CyberKnife
🇺🇸Austin, Texas, United States
Premier Cancer Centers
🇺🇸Dallas, Texas, United States
St. Luke's Medical Center
🇺🇸Houston, Texas, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Cyberknife of Texas at East Texas Medical Center
🇺🇸Tyler, Texas, United States
PeaceHealth Southwest Medical Center
🇺🇸Vancouver, Washington, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Spokane CyberKnife
🇺🇸Spokane Valley, Washington, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Colorado CyberKnife
🇺🇸Lafayette, Colorado, United States
Penrose Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Phoenix CyberKnife & Radiation Oncology Center
🇺🇸Phoenix, Arizona, United States
Scripps Clinic Radiation Therapy Centers
🇺🇸San Diego, California, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
The START Center for Cancer Care
🇺🇸San Antonio, Texas, United States
Baptist Health
🇺🇸Lexington, Kentucky, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States