Status:
COMPLETED
CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Lead Sponsor:
Accuray Incorporated
Conditions:
Prostate Cancer
Prostatic Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 qual...
Detailed Description
In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by High Dose Rate (HDR) brachytherapy treatment, without the use of invasive catheters. Th...
Eligibility Criteria
Inclusion
- Patient must be at least 18 years of age
- Histologically proven prostate adenocarcinoma
- Biopsy within 1 year of date of registration
- Clinical Stage (CS) T1b-T2b, N0, M0
- Patients belonging to one of the following risk categories:
- Low Risk: CS T1b-T2a, Gleason Score 2-6, Prostate Specific Antigen (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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion
- Clinical Stage T2c or greater
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy of 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
Key Trial Info
Start Date :
October 22 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00643617
Start Date
October 22 2007
End Date
April 7 2022
Last Update
May 9 2023
Active Locations (18)
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1
Mitchell Cancer Center University of South Alabama
Mobile, Alabama, United States, 36604
2
Community Regional Medical Center
Fresno, California, United States, 93721
3
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
4
Pasadena Cyberknife Center
Pasadena, California, United States, 91105