An Extension Study MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
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|ClinicalTrials.gov Identifier: NCT04240639|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms of the Prostate||Device: AuroShell particle infusion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: AuroShell particle infusion
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.
Device: AuroShell particle infusion
Infuse AuroShell particles for irradiation by AuroLase laser to ablate neoplasms of the prostate.
- Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) confirmed using 3T MRI/Ultrasound guided biopsy 3 months after treatment. [ Time Frame: Six Months ]To determine the efficacy at 6 months post treatment of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation. MRI/US Fusion biopsy of the treatment zone at both time points post treatment will assess presence of clinically significant prostate disease as confirmed by pathology.
- Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) [ Time Frame: One Year ]To determine the efficacy at 1-year post treatment of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation. MRI/US Fusion biopsy of the treatment zone at both time points post treatment will assess presence of clinically significant prostate disease as confirmed by pathology.
- Adverse Events [ Time Frame: Day One to One Year ]Any adverse device effects attributable to near infrared illumination of the prostate following AuroShell particle infusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240639
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Arvin George, M.D. 734-936-5754 firstname.lastname@example.org|
|Principal Investigator: Arvin George, M.D.|
|United States, Minnesota|
|Mayo Clinic Urology||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Lance A Mynderse, M.D. 507-284-2511|
|Principal Investigator: Lance A Mynderse, M.D.|
|Sub-Investigator: Robert McLaren, M.D.|
|United States, Missouri|
|Washington University in St. Louis||Not yet recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Gerald Andriole, M.D. 314-362-8200|
|Principal Investigator: Gerald Andriole, M.D|
|Sub-Investigator: Eric Kim, M.D.|
|Sub-Investigator: Arjun Sivaraman, M.D.|
|United States, New York|
|Lenox Hill/Northwell Health System||Not yet recruiting|
|New York, New York, United States, 10075|
|Contact: Ardeshir R Rastinehad, D.O. 212-434-4650|
|Principal Investigator: Ardeshir R Rastinehad, D.O.|
|United States, North Carolina|
|Duke University School of Medicine||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Thomas J Polascik, M.D. 919-684-2446|
|Principal Investigator: Thomas J Polascik, M.D.|
|United States, Texas|
|University of Texas Medical School at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Steven Canfield, M.D. 713-500-7335 Steven.Canfield@uth.tmc.edu|
|Principal Investigator: Steven Canfield, M.D.|
|United States, Utah|
|Huntsman Cancer Institute/University of Utah||Not yet recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Alejandro Sanchez, M.D. 801-587-4381|
|Principal Investigator: Alejandro Sanchez, M.D.|
|Sub-Investigator: Jonathan Tward, M.D.|