Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)
Prostate Cancer Early Risk Treated by Radiosurgery
Prostate Cancer Intermediate Risk Treated by Radiosurgery
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial|
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Treatment Outcomes [ Time Frame: 5 years ] [ Designated as safety issue: No ]Measurement of surrogate outcomes including IPSS and SHIM scores
- Treatment toxicity [ Time Frame: 5 years ] [ Designated as safety issue: No ]urinary and rectal complications as well as sexual health
- Assess biochemical disease free survival using PSA [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2020|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226004
|Contact: Mark L Perman, MDemail@example.com|
|Contact: Debra E Freeman, MDfirstname.lastname@example.org|
Show 44 Study Locations
|Principal Investigator:||Mark L. Perman, MD||South Florida Radiation Oncology, LLC.|