Neoplasms of the Prostate Clinical Trial
Official title:
A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.
This is an open-label, multi-center, single-dose study of AuroLase Therapy in the focal ablation of prostate tissue via nanoparticle directed irradiation. The patient population consists of men with low to intermediate risk localized prostate cancer with MRI visible and confirmed focal areas of prostate cancer using MR US Fusion Guided Biopsy. There is one arm/group to this study: Up to sixty (60) patients will receive a single intravenous infusion of AuroShell particles 12 to 36 hours prior to MRI/US guided laser irradiation using an FDA cleared laser and an interstitial optical fiber diffuser. Efficacy and acute volume of ablation will be assessed by contrast-enhanced MRI 48 - 96 hours after laser illumination to allow time for the appearance of coagulative necrosis and prior to reconfiguration of tissue by lytic action. An appearance of a 'void' (e.g., lack of contrast in ablation zone) on MRI would be more generally expected than lesion shrinkage. Efficacy of focal ablation of prostate tissue will be assessed by MRI /Ultrasound guided target biopsy 6 months after laser treatment and at 1 year via MRI /Ultrasound guided target biopsy in combination with standard systematic biopsy. Per standard of care, patient follow up will continue beyond the one year study visit but will be outside the scope of the study. Patients will be consented for up to 5 years in order to track their disease status and progression or recurrence if any. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02680535 -
MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
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N/A |