Trial of NanoPac Focal Therapy for Prostate Cancer

Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy

This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.

NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, this submicron particle paclitaxel will be injected directly into the prostate lesion in men with prostate cancer scheduled for prostatectomy on up to three different occasions. All subjects in the study will receive NanoPac and will be evaluated to see if NanoPac is safe, well-tolerated, and has an impact on 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.