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Neoplasms of the ProstateNCT02680535

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

A study testing AuroShell particle infusion in people with Neoplasms of the Prostate, run by Nanospectra Biosciences, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 45 years and older, men only
Conditions the study is for
Neoplasms of the Prostate
What is being tested?
AuroShell particle infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
5 sitesUnited States
Study dates
Feb 2016to Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • The University of Texas Medical Branch

    Galveston, Texas, 77555

  • University of Texas Medical School at Houston

    Houston, Texas, 77030

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10019

Other trials in United States

About this study

Official title: A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

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

Read the 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.

Being tested
AuroShell particle infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AuroShell particle infusionDevice

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

Study groups in NCT02680535
Study groupRoleWhat they receive
AuroShell particle infusionExperimentalSingle 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.
Receives: Device: AuroShell particle infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Three Months

Secondary outcomes (2)

  1. Adverse Events

    Any adverse device effects attributable to near infrared illumination of the prostate following AuroShell particle infusion.

    Measured: Start to Three Months

  2. 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.

    Measured: One Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionOct 2020
  4. Study completionOct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02680535
Sponsor's protocol ID
NBI-PC-002
Status last verified
Mar 2021
First submitted
2 Feb 2016
Last updated
3 Mar 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Canfield SE, George AK, Jue JS, Lewis SC, Davenport MS, Tammisetti VS, Maruf M, Borregalaes LD, Kadria-Vili Y, Schwartz JA, West J, Halas NJ, Rastinehad AR. A Multi-Institutional Study of Magnetic Resonance/Ultrasound Fusion-Guided Nanoparticle-Directed Focal Therapy for Prostate Ablation. J Urol. 2024 Dec;212(6):862-872. doi: 10.1097/JU.0000000000004222. Epub 2024 Sep 3.

    PubMed 39226591

  • Jue JS, Coons S, Hautvast G, Thompson SF, Geraats J, Richstone L, Schwartz MJ, Rastinehad AR. Novel Automated Three-Dimensional Surgical Planning Tool and Magnetic Resonance Imaging/Ultrasound Fusion Technology to Perform Nanoparticle Ablation and Cryoablation of the Prostate for Focal Therapy. J Endourol. 2022 Mar;36(3):369-372. doi: 10.1089/end.2021.0266. Epub 2021 Sep 13.

    PubMed 34409850

Questions about this trial

What is this clinical trial studying?

A study testing AuroShell particle infusion in people with Neoplasms of the Prostate, run by Nanospectra Biosciences, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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: Three Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02680535, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

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