NCT02357121

Focal Laser Ablation of Prostate Tissue

Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Focal Laser Ablation	Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance

Timeline

• Start date: 2015-09-17
• Primary completion: 2019-08-20
• Completion: 2019-08-20
• First posted: 2015-02-06
• Last updated: 2020-09-21

Locations

2 sites across 1 country: United States