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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

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
U.S. FDA Resources

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, Senior)
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


  Show 23 Study Locations
Sponsors and Collaborators
Nymox Corporation

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT01620515     History of Changes
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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases