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NCT Number: NCT01620515

Two-Dose Level Evaluation 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.

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Key information

Conditions

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

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

For information concerning this clinical site, please contact Nymox at 800-936-9669., Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NX-1207 2.5 mg

Drug

A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.

NX-1207 15 mg

Drug

A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nymox Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2012
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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