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| Sponsored by: |
Accuray Incorporated |
| Information provided by: | Accuray Incorporated |
| ClinicalTrials.gov Identifier: | NCT00643994 |
Purpose
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
| Condition | Intervention | Phase |
|
Prostate Cancer Prostatic Cancer Prostate Neoplasms Prostatic Neoplasms Cancer of the Prostate |
Radiation: CyberKnife Stereotactic Radiosurgery |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution |
| Estimated Enrollment: | 298 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| Contact: Joanne N Davis, PhD | 248-719-2998 | jdavis@accuray.com |
| Contact: Omar Dawood, MD, MPH | 408-789-4457 | odawood@accuray.com |
| United States, Washington | |||||
| Swedish Cancer Center | Recruiting | ||||
| Seattle, Washington, United States, 98122 | |||||
| Contact: Robert Meier, MD 206-386-6707 | |||||
| Principal Investigator: Robert Meier, MD | |||||
| Accuray Incorporated |
| Study Chair: | Robert Meier, MD | Swedish Cancer Center |
| Study Chair: | Irving Kaplan, MD | Beth Isreal Deaconess Medical Center |
| Study Chair: | Martin Sanda, MD | Beth Israel Deaconess Medical Center |
More Information
Accuray Website 
  |
| Responsible Party: | Accuray Incorporated ( Omar Dawood, Vice President of Clinical Development ) |
| Study ID Numbers: | ACCP001.0 |
| First Received: | March 20, 2008 |
| Last Updated: | March 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00643994 |
| Health Authority: | United States: Institutional Review Board |
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