Clinical Trial Details

NCT ID: NCT03077659
Date Last Changed: October 4, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using NanoPac® for patients with Adenocarcinoma of the Prostate

Research Study Title

Phase IIa Dose Escalation Trial of NanoPac® Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy

Purpose

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.

To Learn more

Recruitment Details

Phase
2
Gender
Male
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
NanOlogy, LLC
Duration
8 Months
Facility Type
N/A
Compensation

Eligibility

Male ages 18 Years and up

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

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.

Site Locations (1)

Country State City Zip Facility and Contact
United States California Los Angeles 90033 University of Southern California
Ileana Aldana, MPH
323-865-0702
ileana.aldana@med.usc.edu

Inderbir Gill, MD
Principal Investigator

Contact

Shelagh Verco, PhD
805-595-1300
E-mail:

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