Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01226004 |
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Recruitment Status :
Recruiting
First Posted : October 21, 2010
Last Update Posted : August 6, 2019
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Sponsor:
Florida Robotic Radiosurgery Association
Information provided by (Responsible Party):
Florida Robotic Radiosurgery Association
| Tracking Information | |||||||||
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| First Submitted Date | October 20, 2010 | ||||||||
| First Posted Date | October 21, 2010 | ||||||||
| Last Update Posted Date | August 6, 2019 | ||||||||
| Study Start Date | July 2010 | ||||||||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Overall survival [ Time Frame: 5 years ] | ||||||||
| Original Primary Outcome Measures |
Overall survival [ Time Frame: three years ] | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Multi-Institutional Registry for Prostate Cancer Radiosurgery | ||||||||
| Official Title | Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Men over 18 who have early or intermediate risk prostate cancer and have chosen to undergo radiosurgical treatment | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
3000 | ||||||||
| Original Estimated Enrollment |
300 | ||||||||
| Estimated Study Completion Date | July 2020 | ||||||||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT01226004 | ||||||||
| Other Study ID Numbers | FRRA01 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Florida Robotic Radiosurgery Association | ||||||||
| Study Sponsor | Florida Robotic Radiosurgery Association | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Florida Robotic Radiosurgery Association | ||||||||
| Verification Date | August 2019 | ||||||||