Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
18 Years
N/A
Male
Prostate Cancer, Prostatic Cancer, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate
Trial Information
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
10 years
Safety Issue:
No
Principal Investigator
Donald B Fuller, MD
Investigator Role:
Study Chair
Investigator Affiliation:
CyberKnife Centers at San Diego, CA
Authority:
United States: Institutional Review Board
Study ID:
ACCP002.2
NCT ID:
NCT00643617
Start Date:
November 2007
Completion Date:
January 2019
Related Keywords:
- Prostate Cancer
- Prostatic Cancer
- Prostatic Neoplasms
- Prostate Neoplasms
- Cancer of the Prostate
- Prostate Cancer
- CyberKnife
- Stereotactic Radiosurgery
- Radiosurgery
- Prostate Tumor
- Prostate Surgery
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| St. Anthony Hospital | Oklahoma City, Oklahoma 73101 |
| Long Beach Memorial Medical Center | Long Beach, California 90806 |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Penrose Cancer Center | Colorado Springs, Colorado 80933 |
| AtlantiCare Regional Medical Center | Pomona, New Jersey 08240 |
| University of North Carolina | Chapel Hill, North Carolina 27599 |
| Elmhurst Memorial Hospital | Elmhurst, Illinois 60126 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| East Texas Medical Center | Tyler, Texas 75701 |
| Community Regional Medical Center | Fresno, California 93721 |
| Mitchell Cancer Center University of South Alabama | Mobile, Alabama 36604 |
| Pasadena Cyberknife Center | Pasadena, California 91105 |
| CyberKnife Centers of San Diego | San Diego, California 92101 |
| Colorado Cyberknife | Lafayette, Colorado 80026 |
| New Millenium CyberKnife | Brandon, Florida 33511 |
| JFK Comprehensive Cancer Center | Lake Worth, Florida 33461 |
| South Florida Radiation Oncology | Wellington, Florida 33449 |
| Benefis Health System - Sletten Cancer Institute | Great Falls, Montana 59405 |
