Status:
COMPLETED
Laser Based Focal Ablation of Low Grade Prostate Cancer
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Visualase, Inc.
Conditions:
Low Grade Prostate Cancer
Eligibility:
MALE
45+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.
Eligibility Criteria
Inclusion
- Male, 45 years of age or older
- 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
- Previous surgery, radiation, or androgen deprivation therapy for prostate cancer
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01192438
Start Date
January 1 2010
End Date
September 1 2011
Last Update
March 27 2014
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60616