Trial record 2 of 2724 for:    "Prostatic Neoplasms"

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Accuray Incorporated
ClinicalTrials.gov Identifier:
NCT00643617
First received: March 20, 2008
Last updated: June 23, 2014
Last verified: June 2014
  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 2

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: Emulating HDR Brachytherapy Dosimetry

Resource links provided by NLM:


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: 10 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: 10 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: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 253
Study Start Date: November 2007
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: CyberKnife Stereotactic Radiosurgery
    38 Gy delivered in 4 fractions of 9.5 Gy per fraction
    Other Name: CyberKnife
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643617

Locations
United States, Alabama
Mitchell Cancer Center University of South Alabama
Mobile, Alabama, United States, 36604
United States, California
Community Regional Medical Center
Fresno, California, United States, 93721
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Pasadena Cyberknife Center
Pasadena, California, United States, 91105
CyberKnife Centers of San Diego
San Diego, California, United States, 92101
United States, Colorado
Penrose Cancer Center
Colorado Springs, Colorado, United States, 80907
Colorado Cyberknife
Lafayette, Colorado, United States, 80026
United States, Florida
New Millenium CyberKnife
Brandon, Florida, United States, 33511
JFK Comprehensive Cancer Center
Lake Worth, Florida, United States, 33461
South Florida Radiation Oncology
Wellington, Florida, United States, 33449
United States, Illinois
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
United States, Montana
Benefis Health System - Sletten Cancer Institute
Great Falls, Montana, United States, 59405
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
United States, New Jersey
AtlantiCare Regional Medical Center
Egg Harbor Township, New Jersey, United States, 08234
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73102
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
East Texas Medical Center
Tyler, Texas, United States, 75701
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:
No publications provided

Responsible Party: Accuray Incorporated
ClinicalTrials.gov Identifier: NCT00643617     History of Changes
Other Study ID Numbers: ACCP002.2
Study First Received: March 20, 2008
Last Updated: June 23, 2014
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:
Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 01, 2014