Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
NCT ID: NCT01620515
Last Updated: 2017-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
141 participants
INTERVENTIONAL
2012-02-21
2015-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
NX-1207 2.5 mg
NX-1207 2.5 mg
A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
NX-1207 15 mg
NX-1207 15 mg
A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.
Interventions
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NX-1207 2.5 mg
A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
NX-1207 15 mg
A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
85 Years
MALE
No
Sponsors
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Nymox Corporation
INDUSTRY
Responsible Party
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Locations
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For information concerning this clinical site, please contact Nymox at 800-936-9669.
Tucson, Arizona, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Atherton, California, United States
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La Mesa, California, United States
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Long Beach, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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New Britain, Connecticut, United States
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Aventura, Florida, United States
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Naples, Florida, United States
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Jeffersonville, Indiana, United States
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Shreveport, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Las Vegas, Nevada, United States
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Brick, New Jersey, United States
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Albuquerque, New Mexico, United States
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Garden City, New York, United States
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New York, New York, United States
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Myrtle Beach, South Carolina, United States
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Germantown, Tennessee, United States
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Carrollton, Texas, United States
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Salt Lake City, Utah, United States
Countries
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Other Identifiers
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NX03-0040
Identifier Type: -
Identifier Source: org_study_id
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