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CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

This study is currently recruiting participants.
Verified by Accuray Incorporated, March 2008

Sponsored by: Accuray Incorporated
Information provided by: Accuray Incorporated
ClinicalTrials.gov Identifier: NCT00643617
  Purpose

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

MedlinePlus related topics:   Cancer   Prostate Cancer  

U.S. FDA Resources

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

Further study details as provided by Accuray Incorporated:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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)

Intervention Details:
    Radiation: CyberKnife Stereotactic Radiosurgery
    38 Gy delivered in 4 fractions of 9.5 Gy per fraction
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patient must be at least 18 years of age
  • Histologically proven prostate adenocarcinoma
  • Biopsy within 1 year of date of registration
  • Clinical Stage T1b-T2b, N0, M0
  • Patients belonging to one of the following risk categories:
  • Low Risk: CS T1b-T2a, Gleason Score 2-6, PSA < or = 10 ng/ml
  • Intermediate Risk: CS T2b, Gleason Score 2-6, PSA < or = 10 ng/ml or CS T1b-T2b, Gleason Score 2-6, PSA < or = 20 ng/ml or CS T1b-T2b, Gleason Score 7 and PSA < or = 10 ng/ml
  • Prostate Volume < or = 100 cc
  • ECOG performance status 0-1

Exclusion Criteria:

  • Clinical Stage T2c or greater
  • Prior prostatectomy or cryotherapy of the prostate
  • Prior radiotherapy fo the prostate or lower pelvis
  • Implanted hardware or other material that would prohibit appropriate treatment planning or delivery
  • History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years
  • Hormone ablation for two months prior to enrollment or during treatment
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643617

Contacts
Contact: Joanne N Davis, PhD     248-719-2998     jdavis@accuray.com    
Contact: Omar Dawood, MD     408-789-4457     odawood@accuray.com    

Locations
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            

Sponsors and Collaborators
Accuray Incorporated

Investigators
Study Chair:     Donald B Fuller, MD     CyberKnife Centers at San Diego, CA    
Study Chair:     Chad Lee, PhD     CyberKnife Centers of San Diego, CA    
  More Information

Accuray Website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Accuray Incorporated ( Omar Dawood, MD, MPH )
Study ID Numbers:   ACCP002.0
First Received:   March 20, 2008
Last Updated:   March 20, 2008
ClinicalTrials.gov Identifier:   NCT00643617
Health Authority:   United States: Institutional Review Board

Keywords provided by Accuray Incorporated:
Prostate Cancer  
CyberKnife  
Stereotactic Radiosurgery  
Radiosurgery
Prostate Tumor
Prostate Surgery

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 03, 2008




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