Laser Based Focal Ablation of Low Grade Prostate Cancer
NCT ID: NCT01192438
Last Updated: 2014-03-27
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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COMPLETED
NA
9 participants
INTERVENTIONAL
2010-01-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Procedure/surgery
Laser-based thermotherapy
MRI-guided transperineal placement of a laser probe into the prostate
Interventions
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Laser-based thermotherapy
MRI-guided transperineal placement of a laser probe into the prostate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of prostate adenocarcinoma
* Clinical stage T1c or T2a
* Gleason score of 7 or less
* A minimum of 12 biopsy cores sampled during diagnostic biopsy
* Three or fewer biopsy cores with prostate cancer
* No single biopsy core with greater than 50% of tumor involvement
* A radiographically visible prostate lesion on MRI with concordance to biopsy sextant
* A documented Karnofsky performance status of at least 70
* Estimated survival of 20 years or greater, as determined by treating physician
* Ability to give informed consent
Exclusion Criteria
* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
* History of previous pelvic radiation
* Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A)
* History of other primary non-skin malignancy within previous three years
45 Years
MALE
No
Sponsors
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Visualase, Inc.
INDUSTRY
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Scott E Eggener, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Other Identifiers
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09-364A
Identifier Type: -
Identifier Source: org_study_id
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