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

Tracking Information

First Received Date ^ICMJE

March 20, 2008

Last Updated Date

September 29, 2009

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00643617 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Prostate Cancer
Prostatic Cancer
Prostatic Neoplasms
Prostate Neoplasms
Cancer of the Prostate

Intervention ^ICMJE

Radiation: CyberKnife Stereotactic Radiosurgery

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

253

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00643617

Responsible Party

Omar Dawood, MD, MPH, Accuray Incorporated

Study ID Numbers ^ICMJE

ACCP002.1

Study Sponsor ^ICMJE

Accuray Incorporated

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Accuray Incorporated

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP