Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)
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|ClinicalTrials.gov Identifier: NCT01226004|
Recruitment Status : Recruiting
First Posted : October 21, 2010
Last Update Posted : March 10, 2015
|Condition or disease|
|Prostate Cancer Early Risk Treated by Radiosurgery Prostate Cancer Intermediate Risk Treated by Radiosurgery|
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.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2020|
- Overall survival [ Time Frame: 5 years ]
- Treatment Outcomes [ Time Frame: 5 years ]Measurement of surrogate outcomes including IPSS and SHIM scores
- Treatment toxicity [ Time Frame: 5 years ]urinary and rectal complications as well as sexual health
- Assess biochemical disease free survival using PSA [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226004
|Contact: Mark L Perman, MDemail@example.com|
|Contact: Debra E Freeman, MDfirstname.lastname@example.org|
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|Principal Investigator:||Mark L. Perman, MD||South Florida Radiation Oncology, LLC.|