Trial of NanoPac Focal Therapy for Prostate Cancer

• Status: Terminated
• Trial end date: 2021-02-08
• Target enrollment: 0
• Participant gender: Male

Summary

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

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

Details

• Lead Sponsor: NanOlogy, LLC
• Collaborator: US Biotest, Inc.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• At least 18 years of age;

• Histopathologically proven adenocarcinoma of the prostate:

• Localized cancer;

• Subjects with tumors classified as- 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.