Trial of NanoPac Focal Therapy for Prostate Cancer

NCT ID: NCT04221828

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2021-02-08

Brief Summary

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

Detailed Description

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Adenocarcinoma; Prostatic Neoplasm; Urogenital Neoplasms; Genital Neoplasms, Male; Localized Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NanoPac

Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.

Group Type: EXPERIMENTAL

NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension

Intervention Type: DRUG

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.

Interventions

NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension

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 Type: DRUG

Other Intervention Names

paclitaxel

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

US Biotest, Inc.

INDUSTRY

Sponsor Role: collaborator

NanOlogy, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shelagh Verco, PhD

Role: STUDY_DIRECTOR

US Biotest, Inc.

Locations

Moffitt Cancer Center

Tampa, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Henry Ford Health System

Detroit, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NANOPAC-2019-01

Identifier Type: -

Identifier Source: org_study_id