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| Descriptive Information Fields | |||||||||||||
| Brief Title † | CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution | ||||||||||||
| Official Title † | Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution | ||||||||||||
| Brief Summary | The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer. |
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| Detailed Description | 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 estimate, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities observed following CyberKnife treatment for prostate cancer. [ Time Frame: 5 years ] [ Designated as safety issue: No ] To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix and ASTRO definitions, following CyberKnife treatment. [ Time Frame: 5 years ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, overall survival and quality of life following CyberKnife treatment in prostate cancer patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||||||
| Condition † | Prostate Cancer Prostatic Cancer Prostate Neoplasms Prostatic 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 † | 298 | ||||||||||||
| Start Date † | December 2007 | ||||||||||||
| Completion Date | January 2014 | ||||||||||||
| Eligibility Criteria † | Inclusion Criteria:
Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml
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 † | NCT00643994 | ||||||||||||
| Organization ID | ACCP001.0 | ||||||||||||
| 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 | ||||||||||||