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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


Phase 2
45 Years
85 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.

Outcome Description:

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.

Outcome Time Frame:

Baseline to 45 days post-treatment

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

NX03-0040

NCT ID:

NCT01620515

Start Date:

June 2012

Completion Date:

May 2013

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Prostate Cancer
  • Localized Prostate Cancer
  • T1c Prostate Cancer
  • Focal Therapy
  • NX-1207
  • Prostatic Neoplasms

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