CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry - Full Text View

Sponsor:	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

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

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 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:

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
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
Community Regional Medical Center	Recruiting
Fresno, California, United States, 93721
Contact: Bonnie Harkins 559-451-3647
Principal Investigator: Doug Wong, MD, PhD
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
United States, Colorado
Penrose Cancer Center	Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Jodi Harr 719-776-5270 jodiharr@centura.org
Principal Investigator: Anuj Peddada, MD
Sub-Investigator: Alan Monroe, MD
United States, Montana
Benefis Health System - Sletten Cancer Institute	Recruiting
Great Falls, Montana, United States, 59405
Contact: Kerry Claar 406-731-8240 clinicalresearch@benefis.net
Principal Investigator: Kelly Underhill, MD
United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Patricia Robinson, RN 919-996-4432 probins@med.unc.edu
Principal Investigator: David Morris, MD
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

Sponsors and Collaborators

Accuray Incorporated

Investigators

Study Chair:	Donald B Fuller, MD	CyberKnife Centers at San Diego, CA
Study Chair:	George Mardirossian, PhD	CyberKnife Centers of San Diego, CA

More Information

Additional Information:

Accuray Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Accuray Incorporated ( Omar Dawood, MD, MPH )
Study ID Numbers:	ACCP002.1
Study First Received:	March 20, 2008
Last Updated:	September 29, 2009
ClinicalTrials.gov Identifier:	NCT00643617 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Accuray Incorporated:

Prostate Cancer
CyberKnife
Stereotactic Radiosurgery

Radiosurgery
Prostate Tumor
Prostate Surgery

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009