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Sponsored by: |
Accuray Incorporated |
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Information provided by: | Accuray Incorporated |
ClinicalTrials.gov Identifier: | NCT00643617 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer Prostatic Cancer Prostatic Neoplasms Prostate Neoplasms Cancer of the Prostate |
Radiation: CyberKnife Stereotactic Radiosurgery |
Phase II |
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: Emulating HDR Brachytherapy Dosimetry |
Estimated Enrollment: | 253 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joanne N Davis, PhD | 248-719-2998 | jdavis@accuray.com |
Contact: Omar Dawood, MD | 408-789-4457 | odawood@accuray.com |
United States, California | |
CyberKnife Centers of San Diego | Recruiting |
San Diego, California, United States, 92101 | |
Contact: Carlyn Tripp 619-230-0400 ctripp@rmgmed.com | |
Principal Investigator: Donald B Fuller, MD | |
Community Regional Medical Center | Recruiting |
Fresno, California, United States, 93721 | |
Contact: Bonnie Harkins 559-451-3647 | |
Principal Investigator: Doug Wong, MD, PhD | |
United States, Montana | |
Benefis Health System - Sletten Cancer Institute | Recruiting |
Great Falls, Montana, United States, 59405 | |
Contact: Kerstin Leigland 406-731-8240 | |
United States, Oklahoma | |
St. Anthony Hospital | Recruiting |
Oklahoma City, Oklahoma, United States, 73102 | |
Contact: Vikki Harriott 405-272-7311 | |
Principal Investigator: Clinton A Medbery, III, MD | |
United States, Texas | |
East Texas Medical Center | Recruiting |
Tyler, Texas, United States, 75701 | |
Contact: Misty Weathers 903-595-5550 | |
Principal Investigator: Heidi McKellar, MD | |
Sub-Investigator: Jim Kolker, MD |
Study Chair: | Donald B Fuller, MD | CyberKnife Centers at San Diego, CA |
Study Chair: | Chad Lee, PhD | CyberKnife Centers of San Diego, CA |
Responsible Party: | Accuray Incorporated ( Omar Dawood, MD, MPH ) |
Study ID Numbers: | ACCP002.0 |
Study First Received: | March 20, 2008 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00643617 |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer CyberKnife Stereotactic Radiosurgery |
Radiosurgery Prostate Tumor Prostate Surgery |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |