Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • At least 18 years of age;
  • Histopathologically proven adenocarcinoma of the prostate:
  • Localized cancer;
  • Patients with tumors classified as <T3 per TNM classification, Gleason grade ≥ 6;
  • Prostate tumor must be able to be visualized on mpMRI;
  • Considered to be candidate for radical prostatectomy and 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
  • Creatinine <2 mg/dL
  • 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;
  • 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 patient'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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Open-label, single group, safety, efficacy, and pharmacokinetic study.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: 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.
    Other names:
    • paclitaxel

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Jane Ledesma
913-588-5000
KUCCCTOGUTrialReferral@kumc.edu

More Details

Status
Recruiting
Sponsor
NanOlogy, LLC

Study Contact

Helen Thomas
416-707-6595
helen.thomas@usbiotest.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.