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 neoplastic 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. The patient also has no disease detected via ultrasound guided biopsy outside of areas visualized on MR imaging.There is one arm/group to this study: Up to forty five (45) 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. 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' on MRI would be more generally expected than lesion shrinkage. Efficacy of focal ablation of prostate tissue will be assessed by MRI /Ultrasound guided biopsy at 3 months (primary endpoint) and again at 1 year after laser treatment. Per standard of care patient follow up will continue on a 6 month basis beyond the one year follow up but will be outside the scope of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Infuse AuroShell particles for irradiation by AuroLase laser to ablate neoplasms of the prostate.
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The University of Texas Medical Branch
Galveston, Texas, United States
Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) confirmed using 3T MRI/Ultrasound guided biopsy 3 months after treatment.
Efficacy of focal ablation will be assessed by 3T MRI/Ultrasound guided biopsy at 3 months after treatment. Focal ablation of clinically significant targeted prostate lesions(s) as confirmed with negative biopsies with minimal damage to surrounding healthy tissue.
Time frame: Three Months
Adverse Events
Any adverse device effects attributable to near infrared illumination of the prostate following AuroShell particle infusion.
Time frame: Start to Three Months
Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) confirmed using 3T MRI/Ultrasound guided biopsy one year after treatment.
Efficacy of focal ablation will be assessed by 3T MRI/Ultrasound guided biopsy at one year after treatment. Focal ablation of clinically significant targeted prostate lesions(s) as confirmed with negative biopsies with minimal damage to surrounding healthy tissue.
Time frame: One Year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Texas Medical School at Houston
Houston, Texas, United States