Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

Inclusion Criteria:

* Male; 18 years of age and older
* Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned radical prostatectomy; appropriate for treatment with paclitaxel therapy
* ECOG of 0 or 1
* 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
  * Creatinine \<2 mg/dL
  * Normal PT/INR and PTT;
* Willing to use appropriate contraception from time of NanoPac® injection until prostatectomy
* Willing to receive an mpMRI

Exclusion Criteria:

* Evidence of locally advanced or metastatic disease;
* Prostate size ≥ 50 cc
* Prior prostatectomy
* 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) prior to surgery
* Treatment with a prior investigational agent within 30 days of first dose of investigational medication
* Any previous local treatment of the prostate (i.e. radiation)
* Any other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule
* Known sensitivity to any of the study medication components
* History of prior malignancy that has not been in remission for \>5 years, with the exception of basal cell or squamous cell carcinoma.