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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 : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Nanospectra Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE January 21, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date February 25, 2020
Actual Study Start Date  ICMJE January 30, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
Official Title  ICMJE A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
Brief Summary To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms of the Prostate
Intervention  ICMJE Device: AuroShell particle infusion
Infuse AuroShell particles for irradiation by AuroLase laser to ablate neoplasms of the prostate.
Study Arms  ICMJE 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.
Intervention: Device: AuroShell particle infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 21, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have documented histological or cytological evidence of tumor(s) of the prostate.
  • Patients must be ≥ 45 years of age
  • Patients or their legal representative must be able to read, understand and sign an informed consent
  • Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging
  • Prostate cancer is diagnosed by MR image guided biopsies
  • Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy.
  • A non MRI visible cancer detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible cancer is singularly located in the contralateral hemisphere of the prostate; is Gleason 6 cancer; and comprises no more than 6mm linear extent of cancer in a single core on standard biopsy.
  • If any standard biopsy cores are positive on the same hemisphere of the prostate gland, they must be confirmed as likely to form a contiguous lesion with the target lesion detected on MRI and therefore be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (e.g., Left/Right, Base, Mid Gland, Apex).
  • Prior mpMRI results dated within 120 days prior to ablation.
  • No metastatic disease as per NCCN guidelines (www.nccn.org) - Bone scan indicated to r/o metastatic disease if clinical T1 and PSA > 20 or T2 and PSA > 10
  • PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml
  • The patient has given written informed consent after the nature of the study and alternative treatment options have been explained.

Exclusion Criteria:

  • Patients with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold).
  • Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in questions prior to the day of dosing with PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
  • Patients with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC (101.3 ºF) within 3 days of the first scheduled day of dosing
  • Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
  • The presence of 3 or more MR Visible lesions positive on biopsy.
  • The presence of extra capsular, seminal vesicle invasion or metastatic disease.
  • Patient is unable to tolerate MRI (foreign body; i.e. pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil, etc.…)
  • Patient with inability to follow up.
  • History of prior treatment for prostate cancer.
  • Acute urinary tract infection.
  • Lower urinary tract symptoms defined by International Prostate symptom score (IPSS) > 20
  • Patients with renal insufficiency with an estimated glomerular filtration (EGF) <= 30 are excluded, as they will not be able to undergo gadolinium enhance MRI.
  • Patients with acute or chronic hepatic dysfunction as evidenced by clinically important (> grade 1) changes in AST, ALT, bilirubin, or albumin, or either ALP or GGT values.
  • Patients with uncontrolled coagulopathies who are at increased risk of bleeding, or with abnormal PT (INR) or PTT.
  • Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes.
  • Other medical or surgical conditions, especially involving the cardiac, respiratory, renal or hepatic organ systems that would either be unsafe for the patient, would limit study participation, or that would impede the determination of causality of any adverse events experienced during the conduct of this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04240639
Other Study ID Numbers  ICMJE NBI-PC-002.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nanospectra Biosciences, Inc.
Study Sponsor  ICMJE Nanospectra Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nanospectra Biosciences, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP