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

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ClinicalTrials.gov Identifier: NCT01620515
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: NX-1207 2.5 mg Drug: NX-1207 15 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 21, 2012
Actual Primary Completion Date : October 21, 2015
Actual Study Completion Date : October 21, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change in tumor grade in the region of the baseline prostate cancer [ Time Frame: Baseline to 45 days post-treatment ]
  2. Change in tumor volume in the region of the baseline prostate cancer [ Time Frame: Baseline to 45 days post-treatment ]
  3. Change in tumor grade for the whole prostate [ Time Frame: Baseline to 45 days post-treatment ]
  4. Change in tumor volume in the whole prostate [ Time Frame: Baseline to 45 days post-treatment ]


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620515


Locations
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United States, Arizona
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Tucson, Arizona, United States, 85715
United States, California
For information concerning this clinical site, please contact Nymox at 800-936-9669.
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
United States, Colorado
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Denver, Colorado, United States, 80220
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Englewood, Colorado, United States, 80113
United States, Connecticut
For information concerning this clinical site, please contact Nymox at 800-936-9669.
New Britain, Connecticut, United States, 06052
United States, Florida
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Aventura, Florida, United States, 33180
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Naples, Florida, United States, 34102
United States, Indiana
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Shreveport, Louisiana, United States, 71106
United States, Maryland
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Annapolis, Maryland, United States, 21401
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Baltimore, Maryland, United States, 21204
United States, Nevada
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Las Vegas, Nevada, United States, 89148
United States, New Jersey
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Brick, New Jersey, United States, 08724
United States, New Mexico
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Albuquerque, New Mexico, United States, 87109
United States, New York
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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
United States, South Carolina
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Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Germantown, Tennessee, United States, 38138
United States, Texas
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Carrollton, Texas, United States, 75010
United States, Utah
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Nymox Corporation
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Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT01620515    
Other Study ID Numbers: NX03-0040
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Keywords provided by Nymox Corporation:
Prostate
Prostate Cancer
Localized Prostate Cancer
T1c Prostate Cancer
Focal Therapy
NX-1207
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases