Trial of NanoPac Focal Therapy for Prostate Cancer

Inclusion Criteria:

At least 18 years of age;

Histopathologically proven adenocarcinoma of the prostate:

Localized cancer;
Subjects with tumors classified as Prostate tumor must be able to be visualized on mpMRI;
Already considered to be candidate for radical prostatectomy;
Considered appropriate for treatment with paclitaxel therapy;

Laboratory requirements:

WBC >2500/mm3
Neutrophil >1500/mm3
Hemoglobin >10 mg/dL
Platelet >100,000/ mm3
AST and ALT <2.5 x ULN
Total bilirubin <1.5 x ULN
Calculated creatinine clearance ≥ 30 ml/min
Normal PT/INR and PTT;
ECOG of 0 or 1;
International Prostate Symptom Score (I-PSS) less than or equal to 20;
If sexually active, willing to use double condoms from time of NanoPac injection until prostatectomy;
Agree to all study procedures and provide signed informed consent;

Exclusion Criteria:

Evidence of locally advanced or metastatic disease;
Prostate size ≥ 50 cc;
Prior prostatectomy, including surgery for any benign condition (such as TURP);
Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) while on study prior to surgery;
Treatment with a prior investigational medication within 30 days of first dose of study agent;
Any previous local treatment of the prostate (e.g. radiation, HIFU, cryotherapy, Focal Irreversible Electroporation, Photodynamic Therapy, Laser Induced Thermometry);
Any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule;
Known sensitivity to any of the study agent components;
History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.