Status:
COMPLETED
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
Lead Sponsor:
Accuray Incorporated
Conditions:
Prostate Cancer
Prostatic Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
Detailed Description
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 delive...
Eligibility Criteria
Inclusion
- Patient must be at least 18 years of age
- Histologically proven prostate adenocarcinoma
- Patients belonging in one of the following risk groups:
- Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and Prostate Specific Antigen (PSA) ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml
- Prostate volume: ≤ 100 cc
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
- Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
- Chemotherapy for a malignancy in the last 5 years
- History of an invasive malignancy (other than this prostate cancer, or 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 :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2021
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT00643994
Start Date
December 1 2007
End Date
January 27 2021
Last Update
May 9 2023
Active Locations (23)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
Scripps Cancer Center - CyberKnife of Southern California at Vista
La Jolla, California, United States, 92037
3
The CyberKnife at Newport Diagnostic Center
Newport Beach, California, United States, 92660
4
Georgetown University
Washington D.C., District of Columbia, United States, 20057