Spots Global Cancer Trial Database for Focal Laser Ablation of Prostate Cancer

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Trial Identification

Brief Title: Focal Laser Ablation of Prostate Cancer

Official Title: Office-based Focal Laser Ablation of Prostate Cancer: An Early Feasibility Study Using MRI/US Image Fusion for Guidance

Study ID: NCT04305925

Conditions

Prostate Cancer

Interventions

Focal Laser Ablation

Study Description

Brief Summary: The primary objective of this study is to evaluate the safety and feasibility of Magnetic-Resonance(MR)-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events.

Detailed Description: The primary objective is to evaluate the safety and feasibility of MR-ultrasound image fusion-guided transrectal-based focal laser ablation (FLA) of prostate cancer using the Orion System, an investigational laser-based interstitial irradiation/thermal soft-tissue ablation system. Safety and feasibility will be determined by analyzing the number, type, and severity of adverse events. In addition, changes in health-related quality of life (HRQOL) will be evaluated using Expanded Prostate Index Composite for Clinical Practice (EPIC-CP), Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and Decision Regret Scale. This is an open-label early feasibility/pilot study to evaluate the safety and feasibility of the Orion System. In this study, the investigators intend to use the investigational Orion system to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy. MRI guidance will be achieved by MRI/ultrasound fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser treatments would be achieved by inserting the fiber into the cancerous regions guided by the Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be used to treat the target region. Subjects will return to clinic 1 week, 1 month, and every 3 months until one year post-FLA to be monitored for adverse events and complete Health Related Quality of Life (HRQOL) questionnaires. Biomarker (PSA) kinetics will also be monitored.