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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT01620515
First received: June 13, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: NX-1207 2.5 mg
Drug: NX-1207 15 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nymox Corporation:

Primary Outcome Measures:
  • Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected. [ Time Frame: Baseline to 45 days post-treatment ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Change in tumor grade in the region of the baseline prostate cancer [ Time Frame: Baseline to 45 days post-treatment ] [ Designated as safety issue: No ]
  • Change in tumor volume in the region of the baseline prostate cancer [ Time Frame: Baseline to 45 days post-treatment ] [ Designated as safety issue: No ]
  • Change in tumor grade for the whole prostate [ Time Frame: Baseline to 45 days post-treatment ] [ Designated as safety issue: No ]
  • Change in tumor volume in the whole prostate [ Time Frame: Baseline to 45 days post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620515

  Show 23 Study Locations
Sponsors and Collaborators
Nymox Corporation
  More Information

No publications provided

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT01620515     History of Changes
Other Study ID Numbers: NX03-0040
Study First Received: June 13, 2012
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014