Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
NCT ID: NCT00969202
Last Updated: 2015-11-18
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
PHASE1
50 participants
INTERVENTIONAL
2009-08-31
2016-12-31
Brief Summary
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The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.
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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Stereotactic Radiosurgery using NovalisTx
Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.
Stereotactic Radiosurgery using the Novalis Tx
Five treatments given every other day.
Interventions
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Stereotactic Radiosurgery using the Novalis Tx
Five treatments given every other day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gleason score ≤ 6 and low volume Gleason 7 (3+4)
* PSA \< 10
* Clinical Stage of T2a or less
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Gleason score \> 7
* PSA \> 10
* Clinical Stage of T2b or greater
18 Years
99 Years
MALE
No
Sponsors
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San Diego Radiosurgery
INDUSTRY
Responsible Party
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Principal Investigators
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P. Brian Volpp, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology
Locations
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San Diego Radiosurgery at Palomar Medical Center
Escondido, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SDRS0001
Identifier Type: -
Identifier Source: org_study_id