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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance
UCLA
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
safety of focal laser treatment using LITT: Number of participants with adverse events
Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.
Time frame: 12 months
Efficacy of focal laser ablation of prostate tissue using the LITT system.
MRI changes will be determined at 6 and 12 months post FLA to assess efficacy.
Time frame: 12 months
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