Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
Condition: Adenocarcinoma of the Prostate
MeSH terms: Prostatic Neoplasms
Intervention: NanoPac®
Intervention description: Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label, dose rising, Phase IIa trial. The study will include a dose escalation phase and a dose confirmation phase. In the dose escalation phase, NanoPac® concentrations of 6, 10, and 15 mg/mL in an injection volume of 20% of the lobe of the prostate containing the dominant lesion will be studied in cohorts of 3, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data the next cohort may begin enrolling, or an additional 3 at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted. The dose determined to be the most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the DSMB, will enroll additional subjects (dose confirmation phase) to provide a cohort of 12 subjects at that dose level.
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; prostatic neoplasms; genital neoplasms, male; urogenital neoplasms; prostatic diseases

Summary:

      Open-label, dose rising, Phase IIa trial of intratumorally-injected NanoPac® 6, 10, or 15
      mg/mL in subjects with prostate cancer scheduled for prostatectomy.
    

Eligibility criteria:

        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.