MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

• ClinicalTrials.gov Identifier: NCT02680535
• Recruitment Status: Active, not recruiting
• First Posted: February 11, 2016
• Last Update Posted: August 28, 2019
• Sponsor: Nanospectra Biosciences, Inc.
• Information provided by (Responsible Party): Nanospectra Biosciences, Inc.

Tracking Information

• First Submitted Date: February 2, 2016
• First Posted Date: February 11, 2016
• Last Update Posted Date: August 28, 2019
• Study Start Date: February 2016
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2016)

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: Three Months ]

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.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: February 16, 2016)

• Adverse Events [ Time Frame: Start to Three Months ]
  Any adverse device effects attributable to near infrared illumination of the prostate following AuroShell particle infusion.
• Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) confirmed using 3T MRI/Ultrasound guided biopsy one year after treatment. [ Time Frame: One Year ]
  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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neoplasms of the Prostate

Intervention

Device: AuroShell particle infusion

Infuse AuroShell particles for irradiation by AuroLase laser to ablate neoplasms of the prostate.

Study Arms

Experimental: AuroShell particle infusion

Single intravenous infusion of AuroShell particles 12 to 36 hours prior to ultrasound-guided laser irradiation using a FDA cleared laser and an interstitial optical fiber.

Intervention: Device: AuroShell particle infusion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 16, 2016): 45
• Original Enrollment: Not Provided
• Estimated Study Completion Date: July 2020
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

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.
• If the standard biopsy cores are positive, they must be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (Left / Right, Base, Mid Gland, Apex).
• Prior MRI 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 question prior to the day of dosing with the 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, due to they will not be able to undergo gadolinium enhance MRI.
• Patients with acute or chronic hepatic dysfunction as evidenced by clinically significant abnormalities in albumin, total protein, or prothrombin time, or evidence of hepatic injury with clinically important (> grade 1) changes in AST, ALT, ALP, bilirubin, or GGT values.
• Patients with uncontrolled coagulopathies who are at increased risk of bleeding.
• 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

• Sexes Eligible for Study: Male

• Ages: 45 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02680535
• Other Study ID Numbers: NBI-PC-002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Nanospectra Biosciences, Inc.
• Study Sponsor: Nanospectra Biosciences, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Nanospectra Biosciences, Inc.
• Verification Date: August 2019