CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
This study is ongoing, but not recruiting participants.
Sponsor:
Accuray Incorporated
Information provided by (Responsible Party):
Accuray Incorporated
ClinicalTrials.gov Identifier:
NCT00643617
First received: March 20, 2008
Last updated: April 5, 2013
Last verified: April 2013
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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:
Detailed Description:
-
Radiation: CyberKnife Stereotactic Radiosurgery
38 Gy delivered in 4 fractions of 9.5 Gy per fraction
Other Name: CyberKnife
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
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: | April 5, 2013 |
| 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 Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013