Trial of NanoPac Focal Therapy for Prostate Cancer
Condition: Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Adenocarcinoma; Prostatic Neoplasm; Urogenital Neoplasms; Genital Neoplasms, Male; Localized Cancer
MeSH terms: Prostatic Neoplasms; Neoplasms; Adenocarcinoma; Urogenital Neoplasms; Genital Neoplasms, Male
Intervention: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
Intervention description: NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single group, safety, efficacy, and pharmacokinetic study.
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: paclitaxel

Summary:

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

Eligibility criteria:

        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.