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

Sponsor:	Accuray Incorporated
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Accuray Incorporated:

Primary Outcome Measures:

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 Measures:

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 ]

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)

Arms	Assigned Interventions
Experimental: CyberKnife Stereotactic Radiosurgery	Radiation: CyberKnife Stereotactic Radiosurgery 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction Other Name: CyberKnife

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.

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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643994

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Locations

United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Scripps Cancer Center - CyberKnife of Southern California at Vista
La Jolla, California, United States, 92037
The CyberKnife at Newport Diagnostic Center
Newport Beach, California, United States, 92660
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
Coastal CyberKnife and Radiation Oncology
Fort Pierce, Florida, United States, 34982
Jupiter Medical Center & CyberKnife Center of Palm Beach
Jupiter, Florida, United States, 33458
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Community Cancer Center
Normal, Illinois, United States, 61761
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
United States, Missouri
Lake Saint Louis Oncology
Saint Louis, Missouri, United States, 63367
Saint Louis University
St. Louis, Missouri, United States, 63367
United States, Nevada
St. Mary's Regional Medical Center
Reno, Nevada, United States, 89503
United States, New Jersey
Capital Health
Trenton, New Jersey, United States, 08618
United States, New York
Hematology Oncology Associates of Central New York
Syracuse, New York, United States, 15057
United States, Virginia
Virginia Hospital Center
Arlington, Virginia, United States, 22205
United States, Washington
Swedish Cancer Center
Seattle, Washington, United States, 98122
Southwest Washington Medical Center
Vancouver, Washington, United States, 98664
Southwest Washington Regional Cancer Center
Vancouver, Washington, United States, 98664
United States, Wisconsin
ThedaCare Appleton Medical Center
Appleton, Wisconsin, United States, 54911

Sponsors and Collaborators

Accuray Incorporated

Investigators

Study Chair:	Robert Meier, MD	Swedish Cancer Center
Study Chair:	Irving Kaplan, MD	Beth Israel Deaconess Medical Center
Study Chair:	Martin Sanda, MD	Beth Israel Deaconess Medical Center

More Information

Additional Information:

Accuray Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Accuray Incorporated
ClinicalTrials.gov Identifier:	NCT00643994 History of Changes
Other Study ID Numbers:	ACCP001.2
Study First Received:	March 20, 2008
Last Updated:	November 1, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Accuray Incorporated:

Prostate Cancer
CyberKnife
Stereotactic Radiosurgery
Radiotherapy

Radiation
Prostate Tumor
Prostate Surgery

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms

Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 28, 2012