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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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