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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

NCT04240639

Description:

To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: An Extension Study MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
  • Official Title: A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

Clinical Trial IDs

  • ORG STUDY ID: NBI-PC-002.1
  • NCT ID: NCT04240639

Conditions

  • Neoplasms of the Prostate

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
AuroShell particle infusionExperimentalSingle 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.

    Eligibility Criteria

            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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:45 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure: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
    Safety Issue:
    Description: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.

    Secondary Outcome Measures

    Measure:Adverse Events
    Time Frame:Day One to One Year
    Safety Issue:
    Description:Any adverse device effects attributable to near infrared illumination of the prostate following AuroShell particle infusion.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Nanospectra Biosciences, Inc.

    Last Updated

    January 23, 2020