Description:
To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.
To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.
Recruiting
N/A
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| 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. |
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 |
| 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. |
| 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. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Nanospectra Biosciences, Inc. |
June 21, 2021