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| Descriptive Information Fields | |||||||||
| Brief Title † | CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry | ||||||||
| Official Title † | Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry | ||||||||
| Brief Summary | The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time. |
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| Detailed Description | In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by HDR brachytherapy treatment, without the use of invasive catheters. The radiosurgery volumes will closely be made to resemble HDR brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues. The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Open Label, Single Group Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | To determine biochemical disease free survival (using both ASTRO and Phoenix definitions) and measure the rates of acute and late genitourinary and gastrointestinal toxicities following CyberKnife radiosurgery. [ Time Frame: 5 years ] [ Designated as safety issue: No ] To compare the CyberKnife biochemical disease free survival rates (bDFS) to published HDR monotherapy bDFS rates reported in the literature. [ Time Frame: 5 years ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | To measure the rates of local failure, distant failure, clinical-disease free survival, disease-specific survival, overall survival and quality of life. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Prostate Cancer Prostatic Cancer Prostatic Neoplasms Prostate Neoplasms Cancer of the Prostate |
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| Intervention † | Radiation: CyberKnife Stereotactic Radiosurgery | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | Accuray Website  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 253 | ||||||||
| Start Date † | November 2007 | ||||||||
| Completion Date | January 2014 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00643617 | ||||||||
| Organization ID | ACCP002.0 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Accuray Incorporated | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Accuray Incorporated | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | March 20, 2008 | ||||||||
| Last Updated Date | March 20, 2008 | ||||||||
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