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Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

NCT03077659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-08-20

Study results available
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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.

Conditions

  • Adenocarcinoma of the Prostate

Interventions

DRUG

NanoPac®

Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.

Sponsors & Collaborators

  • US Biotest, Inc.

    collaborator INDUSTRY

  • NanOlogy, LLC

    lead INDUSTRY

Principal Investigators

  • Shelagh Verco, PhD · US Biotest, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2018-10-04
Completion
2018-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03077659 on ClinicalTrials.gov