Spots Global Cancer Trial Database for Focal Laser Ablation of Prostate Tissue
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Trial Identification
Brief Title: Focal Laser Ablation of Prostate Tissue
Official Title: Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance
Study ID: NCT02357121
Conditions
Interventions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
UCLA, Los Angeles, California, United States
University of California Los Angeles, Los Angeles, California, United States
Contact Details
Name: Leonard Marks, MD
Affiliation: University of California at Los Angeles
Role: PRINCIPAL_INVESTIGATOR
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