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

Sponsored by:	Accuray Incorporated
Information provided by:	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:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

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)

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, California
Scripps Cancer Center - CyberKnife of Southern California at Vista	Recruiting
La Jolla, California, United States, 92037
Contact: Debbie Deseno, RN, BSN 858-652-5465 deseno.debbie@scrippshealth.org
Principal Investigator: Patrick W Linson, MD, MPH
United States, District of Columbia
Georgetown University	Recruiting
Washington, District of Columbia, United States, 20057
Contact: Heather Hanscom Heather.N.Hanscom@georgetown.edu
Principal Investigator: Sean Collins, MD
United States, Florida
Jupiter Medical Center & CyberKnife Center of Palm Beach	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, Maryland
Franklin Square Hospital Center	Recruiting
Baltimore, Maryland, United States, 21237
Contact: Cengiz Aygun, MD
Contact: Linda Stark 410-682-6800 Linda.Stark@medstar.net
Principal Investigator: Cengiz Aygun, MD
Sinai Hospital of Baltimore	Recruiting
Baltimore, Maryland, United States, 21215
Contact: Jennifer Hertsch 410-601-9083 jhertsch@lifebridgehealth.org
Principal Investigator: Mark Brenner, 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, Missouri
Saint Louis University	Recruiting
St. Louis, Missouri, United States, 63367
Contact: Patricia Tapella 314-577-8815 Tapellap@slu.edu
Principal Investigator: Bruce Walz, MD
Lake Saint Louis Oncology	Recruiting
Saint Louis, Missouri, United States, 63367
Contact: Patricia Tapella 314-577-8815 Tapellap@slu.edu
Principal Investigator: Bruce J Walz, 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, New York
Hematology Oncology Associates of Central New York	Recruiting
Syracuse, New York, United States, 15057
Contact: Jeffrey Seeber, MS, DABR 315-472-7504 jseeber@Hoacny.com
Principal Investigator: Dennis Kotlove, MD
United States, Virginia
Virginia Hospital Center	Recruiting
Arlington, Virginia, United States, 22205
Contact: Suzanne Milne, RN 703-558-6284 smilne@virginiahospitalcenter.com
Principal Investigator: Robert L Hong, MD
United States, Washington
Swedish Cancer Center	Recruiting
Seattle, Washington, United States, 98122
Contact: Justine Rees 206-386-6707
Principal Investigator: Robert Meier, MD
United States, Wisconsin
ThedaCare Appleton Medical Center	Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Frances Taylortreder 920-831-5169 fran.taylortreder@thedacare.org
Principal Investigator: Michael Ray, MD, PhD

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 ( Omar Dawood, Vice President of Clinical Development )
Study ID Numbers:	ACCP001.0
Study First Received:	March 20, 2008
Last Updated:	June 24, 2009
ClinicalTrials.gov Identifier:	NCT00643994 History of Changes
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
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 06, 2009