Laser Based Focal Ablation of Low Grade Prostate Cancer
Not Applicable
Completed
- Conditions
- Low Grade Prostate Cancer
- Registration Number
- NCT01192438
- Lead Sponsor
- University of Chicago
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 9
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of patients with adverse events Within 6 months of the procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Chicago🇺🇸Chicago, Illinois, United States