Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Jonsson Comprehensive Cancer Center
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- safety of focal laser treatment using LITT: Number of participants with adverse events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies. Intra-procedure temperature and concurrent rectal wall thermistor monitoring will be performed for internal validation. Subjects will be monitored for adverse events, and health-related quality of life (HRQOL) questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be monitored.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Any significant cancer outside of MRI target (ROI) area, defined as Gleason score \> 3+4
- •\< 10 years life expectancy
- •American Society of Anesthesiologists (ASA) criteria of IV or higher
- •Unfit for conscious sedation anesthesia
- •Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, INR or platelet count (as determined by institutional lab parameters) at the time of screening
- •Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
- •Active urinary tract infection
- •Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
- •Any prior treatment for prostate cancer
- •Radical prostatectomy
Outcomes
Primary Outcomes
safety of focal laser treatment using LITT: Number of participants with adverse events
Time Frame: 12 months
Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.
Secondary Outcomes
- Efficacy of focal laser ablation of prostate tissue using the LITT system.(12 months)