CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
This trial is active, not recruiting.
|Conditions||prostate cancer, prostatic cancer, prostatic neoplasms, prostate neoplasms, cancer of the prostate|
|Treatment||cyberknife stereotactic radiosurgery|
|Start date||November 2007|
|End date||January 2019|
|Trial size||253 participants|
|Trial identifier||NCT00643617, ACCP002.2|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Mobile, AL||Mitchell Cancer Center University of South Alabama||no longer recruiting|
|Fresno, CA||Community Regional Medical Center||no longer recruiting|
|Long Beach, CA||Long Beach Memorial Medical Center||no longer recruiting|
|Pasadena, CA||Pasadena Cyberknife Center||no longer recruiting|
|San Diego, CA||CyberKnife Centers of San Diego||no longer recruiting|
|Colorado Springs, CO||Penrose Cancer Center||no longer recruiting|
|Lafayette, CO||Colorado Cyberknife||no longer recruiting|
|Brandon, FL||New Millenium CyberKnife||no longer recruiting|
|Lake Worth, FL||JFK Comprehensive Cancer Center||no longer recruiting|
|Wellington, FL||South Florida Radiation Oncology||no longer recruiting|
|Elmhurst, IL||Elmhurst Memorial Hospital||no longer recruiting|
|Great Falls, MT||Benefis Health System - Sletten Cancer Institute||no longer recruiting|
|Las Vegas, NV||Comprehensive Cancer Centers of Nevada||no longer recruiting|
|Egg Harbor Township, NJ||AtlantiCare Regional Medical Center||no longer recruiting|
|Chapel Hill, NC||University of North Carolina||no longer recruiting|
|Oklahoma City, OK||St. Anthony Hospital||no longer recruiting|
|Nashville, TN||Sarah Cannon Research Institute||no longer recruiting|
|Tyler, TX||East Texas Medical Center||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with CyberKnife Stereotactic Radiosurgery
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
To compare the CyberKnife biochemical disease free survival rates (bDFS) to published HDR monotherapy bDFS rates reported in the literature.
time frame: 10 years
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
Male participants at least 18 years old.
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
|Official title||Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry|
|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.|
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