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

This is an interventional treatment trial for Neoplasms of the Prostate Read More

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.