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 \<T3 per TNM classification, Gleason score≥ 6;
* 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.