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CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution

This study is currently recruiting participants.
Study NCT00643994.   Last updated on March 20, 2008.   Information provided by Accuray Incorporated

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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.

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.

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 ]
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
Intervention  Radiation: CyberKnife Stereotactic Radiosurgery
MEDLINE PMIDs
Links Accuray Website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  298
Start Date  December 2007
Completion Date January 2014
Eligibility Criteria 

Inclusion Criteria:

  • Patient must be at least 18 years of age
  • Histologically proven prostate adenocarcinoma
  • Patients belonging in one of the following risk groups:

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

  • Prostate volume: ≤ 100 cc
  • ECOG performance status 0-1

Exclusion Criteria:

  • Prior prostatectomy or cryotherapy of the prostate
  • Prior radiotherapy to the prostate or lower pelvis
  • Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
  • Chemotherapy for a malignancy in the last 5 years
  • History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
  • Hormone ablation for two months prior to enrollment, or during treatment.
Gender Male
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Joanne N Davis, PhD     248-719-2998     jdavis@accuray.com    
Contact: Omar Dawood, MD, MPH     408-789-4457     odawood@accuray.com    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00643994
Organization ID ACCP001.0
Secondary IDs ††
Study Sponsor  Accuray Incorporated
Collaborators ††
Investigators 
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    
Information Provided By Accuray Incorporated
Verification Date March 2008
First Received Date  March 20, 2008
Last Updated Date March 20, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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