CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
NCT ID: NCT00643994
Last Updated: 2023-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
379 participants
INTERVENTIONAL
2007-12-31
2021-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CyberKnife Stereotactic Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer.
CyberKnife Stereotactic Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Interventions
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CyberKnife Stereotactic Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
MALE
No
Sponsors
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Accuray Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Meier, MD
Role: STUDY_CHAIR
Swedish Cancer Center
Irving Kaplan, MD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Martin Sanda, MD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Scripps Cancer Center - CyberKnife of Southern California at Vista
La Jolla, California, United States
The CyberKnife at Newport Diagnostic Center
Newport Beach, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Coastal CyberKnife and Radiation Oncology
Ft. Pierce, Florida, United States
Jupiter Medical Center & CyberKnife Center of Palm Beach
Jupiter, Florida, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Lake Saint Louis Oncology
St Louis, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
St. Mary's Regional Medical Center
Reno, Nevada, United States
Capital Health
Trenton, New Jersey, United States
Hematology Oncology Associates of Central New York
Syracuse, New York, United States
Virginia Hospital Center
Arlington, Virginia, United States
Swedish Cancer Center
Seattle, Washington, United States
Southwest Washington Medical Center
Vancouver, Washington, United States
Southwest Washington Regional Cancer Center
Vancouver, Washington, United States
ThedaCare Appleton Medical Center
Appleton, Wisconsin, United States
Countries
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References
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Meier RM, Bloch DA, Cotrutz C, Beckman AC, Henning GT, Woodhouse SA, Williamson SK, Mohideen N, Dombrowski JJ, Hong RL, Brachman DG, Linson PW, Kaplan ID. Multicenter Trial of Stereotactic Body Radiation Therapy for Low- and Intermediate-Risk Prostate Cancer: Survival and Toxicity Endpoints. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):296-303. doi: 10.1016/j.ijrobp.2018.05.040. Epub 2018 Jun 1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Accuray Website
Other Identifiers
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ACCP001.4
Identifier Type: -
Identifier Source: org_study_id
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