Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer
NCT ID: NCT02334579
Last Updated: 2019-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
146 participants
INTERVENTIONAL
2014-12-31
2024-12-31
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
This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.
CyberKnife Stereotactic Radiosurgery
Five treatments given over about one week.
Interventions
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CyberKnife Stereotactic Radiosurgery
Five treatments given over about one week.
Eligibility Criteria
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Inclusion Criteria
* Clinical stage T1a-T3, N0-Nx, M0-Mx
* Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA\<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA\<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 \& \<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20
* Karnofsky performance status 70-100
* Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy
* Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment
* High risk group: three hormone therapy regimens are allowed
* 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed
Exclusion Criteria
* Prior high-dose 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
18 Years
ALL
No
Sponsors
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Swedish Medical Center
OTHER
Responsible Party
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Principal Investigators
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Robert Meier, MD
Role: PRINCIPAL_INVESTIGATOR
Swedish Medical Center Radiosurgery Center
Locations
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Swedish Medical Center Radiosurgery Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Swedish Medical Center Radiosurgery Center
Other Identifiers
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IR 5642
Identifier Type: -
Identifier Source: org_study_id
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