Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

• Status: Completed
• Trial end date: 2018-10-04
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NanOlogy, LLC
• Collaborator: US Biotest, Inc.
• Treatments: Paclitaxel

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.