Neoplasms of the ProstateNCT04240639
An Extension Study 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 8 sites in United States.
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
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Jan 2020to Jun 2023
- 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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- 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.
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 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.
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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, 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48109
Cleveland Clinic
Cleveland, Ohio, 41195
Duke University School of Medicine
Durham, North Carolina, 27710
University of Texas Medical School at Houston
Houston, Texas, 77030
Lenox Hill/Northwell Health System
New York, New York, 10075
Mayo Clinic Urology
Rochester, Minnesota, 55905
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Washington University in St. Louis
St Louis, Missouri, 63110
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 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.
- Conditions
- Neoplasms of the Prostate
- 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 group | Role | What they receive |
|---|---|---|
| AuroShell particle infusion | Experimental | 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. Receives: Device: AuroShell particle infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) confirmed using 3T MRI/Ultrasound guided biopsy 3 months after treatment.
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.
Measured: Six Months
Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s)
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.
Measured: One Year
Secondary outcomes (1)
Adverse Events
Any adverse device effects attributable to near infrared illumination of the prostate following AuroShell particle infusion.
Measured: Day One to One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start30 Jan 2020
- Primary completion31 Dec 2022
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms of the ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanospectra Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240639
- Sponsor's protocol ID
- NBI-PC-002.1
- Status last verified
- May 2023
- First submitted
- 21 Jan 2020
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
- ClinicalTrials.gov ID
- NCT04240639
- Acronym / sponsor ID
- NBI-PC-002.1
- Conditions
- Neoplasms of the Prostate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanospectra Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AuroShell particle infusion | Experimental | Device: AuroShell particle infusionSingle 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AuroShell particle infusionInfuse AuroShell particles for irradiation by AuroLase laser to ablate neoplasms of the prostate. | Device | AuroShell particle infusion |
Primary outcome
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.
1 secondary outcome
Adverse Events
Time frame: Day One to One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
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 8 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 12 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: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
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: Six Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2023.