Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

March 9, 2017 updated by: Nymox Corporation

Phase 2 Multicenter Prospective Open Label 2-Dose Level Clinical Safety and Efficacy Evaluation of Injection of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • California
      • Atherton, California, United States, 94027
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • La Mesa, California, United States, 91942
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Long Beach, California, United States, 90806
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • San Diego, California, United States, 92120
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Colorado
      • Denver, Colorado, United States, 80220
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Englewood, Colorado, United States, 80113
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Connecticut
      • New Britain, Connecticut, United States, 06052
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Florida
      • Aventura, Florida, United States, 33180
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Naples, Florida, United States, 34102
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Baltimore, Maryland, United States, 21204
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • New York
      • Garden City, New York, United States, 11530
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • New York, New York, United States, 10016
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Texas
      • Carrollton, Texas, United States, 75010
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • T1c prostate cancer
  • Gleason score ≤ 6 with no Gleason pattern of 4 or 5.
  • Life expectancy ≥ 5 years.
  • Single positive prostate biopsy core with ≤ 50% cancer
  • PSA ≤ 10 ng/mL

Exclusion Criteria:

  • Previous active treatment (such as surgery, brachytherapy, radiotherapy) for prostate cancer.
  • Evidence of metastatic disease or previous positive bone scan.
  • Previous hormonal therapy for prostate cancer.
  • Use of certain concomitant medications, including 5 alpha reductase inhibitors (e.g. finasteride, dutasteride), androgen receptor blockers (e.g. flutamide, bicalutamide), immunosuppressants(such as Imuran™, Enbrel™, Remicade™, Humira™, etc.), anticoagulants(such as Coumadin™ or heparin), or chemotherapeutics.
  • Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment within the past 12 months.
  • Pelvic irradiation.
  • Urinary tract infection more than once in the past 12 months.
  • Acute or chronic prostatitis in the past 12 months.
  • Clinically significant renal or hepatic impairment.
  • Bleeding disorder.
  • Poorly controlled diabetes type 1 or type 2.
  • Urinary retention in the previous 12 months.
  • Self-catheterization for urinary retention.
  • Post-void residual urine volume > 200 mL.
  • Prior significant rectal surgery or any rectal condition with rectal stenosis or fistula.
  • History of alcohol or substance abuse or dependence within the past 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Active Surveillance
Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer.
Experimental: NX-1207 2.5 mg
Drug: NX-1207 2.5 mg
A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
Experimental: NX-1207 15 mg
Drug: NX-1207 15 mg
A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.
Time Frame: Baseline to 45 days post-treatment
The primary efficacy endpoint is the percentage of subjects with undetectable prostate cancer (negative biopsy) in the region of the prostate where the baseline cancer was detected.
Baseline to 45 days post-treatment
Safety of a single treatment of NX-1207 2.5 mg or NX-1207 15 mg in subjects with biopsy-confirmed low grade low risk localized (T1c) prostate cancer.
Time Frame: Baseline to 60 days post-treatment
Safety will be assessed by physical exam, prostate biopsy, monitoring of adverse events, changes in ECG, and changes in PSA and other clinical laboratory values.
Baseline to 60 days post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in tumor grade in the region of the baseline prostate cancer
Time Frame: Baseline to 45 days post-treatment
Baseline to 45 days post-treatment
Change in tumor volume in the region of the baseline prostate cancer
Time Frame: Baseline to 45 days post-treatment
Baseline to 45 days post-treatment
Change in tumor grade for the whole prostate
Time Frame: Baseline to 45 days post-treatment
Baseline to 45 days post-treatment
Change in tumor volume in the whole prostate
Time Frame: Baseline to 45 days post-treatment
Baseline to 45 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nymox Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2012

Primary Completion (Actual)

October 21, 2015

Study Completion (Actual)

October 21, 2015

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NX03-0040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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