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

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

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: Homogenous Dose Distribution

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)

Intervention Details:

36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction

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

Contacts


Contact: Joanne N Davis, PhD	248-719-2998	jdavis@accuray.com

Contact: Omar Dawood, MD, MPH	408-789-4457	odawood@accuray.com

Locations


United States, Florida
	Jupiter Medical Center	Recruiting
	Jupiter, Florida, United States, 33458
	Contact: Janet Martin 561-745-5768
	Principal Investigator: Eugene Shieh, MD

United States, Illinois
	Northwest Community Hospital	Recruiting
	Arlington Heights, Illinois, United States, 60005
	Contact: Josie Smudde 847-618-6772
	Principal Investigator: Najeeb Mohideen, MD

United States, Kentucky
	Central Baptist Hospital	Recruiting
	Lexington, Kentucky, United States, 40503
	Contact: Theresa Roberts 859-260-6362
	Principal Investigator: Alan Beckman, MD

United States, Massachusetts
	Beth Israel Deaconess Medical Center	Recruiting
	Boston, Massachusetts, United States, 02215
	Contact: Chrys Martin 617-667-4679
	Principal Investigator: Irving Kaplan, MD

United States, Michigan
	St. Joseph's Hospital	Recruiting
	Ann Arbor, Michigan, United States, 48106
	Contact: Ann Novak 734-712-5674
	Principal Investigator: George Henning, MD

United States, New Jersey
	Capital Health	Recruiting
	Trenton, New Jersey, United States, 08618
	Contact: Susan Wall 609-815-7443
	Principal Investigator: Daniel Fram, MD

United States, Washington
	Swedish Cancer Center	Recruiting
	Seattle, Washington, United States, 98122
	Contact: Robert Meier, MD 206-386-6707
	Principal Investigator: Robert Meier, MD

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

Accuray Website This link exits the ClinicalTrials.gov site

Responsible Party:	Accuray Incorporated ( Omar Dawood, Vice President of Clinical Development )
Study ID Numbers:	ACCP001.0
First Received:	March 20, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00643994
Health Authority:	United States: Institutional Review Board

Keywords provided by Accuray Incorporated:

Prostate Cancer

CyberKnife

Stereotactic Radiosurgery

Radiotherapy

Radiation

Prostate Tumor

Prostate Surgery

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Accuray Incorporated
Information provided by:	Accuray Incorporated
ClinicalTrials.gov Identifier:	NCT00643994