For Prospective Patients

AuroLase® Therapy is investigational at this current time and only available through designated FDA sanctioned clinical study sites. Patients must be enrolled by the participating physician at that clinical study site, and must meet the enrollment criteria based on the physician’s evaluation.

 

patients

 

Current Clinical Trials:

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

Click here to view our Aurolase Animation for this study

 

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 (3+4); and 2 or less positive lesions on 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).
  • Original MRI obtained 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 abnormal liver function as evidenced by e.g., albumin, AST, AST/ALT, ALP, bilirubin, total protein values falling outside normal reference ranges.
  • 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 serious illnesses: involving the cardiac, respiratory, CNS, renal or hepatic organ systems, but not limited to which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study as per the discretion of the investigator.

 

Other Types of Cancer

Other cancer applications are under development. Updates regarding future clinical trials will be posted as they become available.

For Patients Previously Treated with AuroShell® Particles

For patients previously treated with AuroShell particles , please contact your treating clinician with any questions. In the event of an emergency, please call 911 or proceed to the nearest emergency room.

 

CLINICAL TRIAL INFORMATION – CLINICAL STUDY SITES

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

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 (3+4); and 2 or less positive lesions on 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).
  • Original MRI obtained 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 abnormal liver function as evidenced by e.g., albumin, AST, AST/ALT, ALP, bilirubin, total protein values falling outside normal reference ranges.
  • 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 serious illnesses: involving the cardiac, respiratory, CNS, renal or hepatic organ systems, but not limited to which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study as per the discretion of the investigator.

 

Sites:

Icahn School of Medicine at Mount Sinai
625 Madison Avenue
NY, NY 10019
Telephone 212.241.9955
Co-Principal Investigator – Ardeshir R. Rastinhad, D.O.

University of Texas Medical School at Houston
6410 Fannin Street, Suite 420
Houston, Texas 77030
Telephone 713.500.7335
Co-Principal Investigator – Steven Canfield. M.D.

Montefiore Weiler Hospital
1825 Eastchester Road
Bronx, NY 10461-2301
Telephone 718.920.5402
Sub-Principal Investigator – Joshua Stern, M.D.

Other cancer applications are also in development. Updates regarding future clinical trials will be posted as they become available.