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

Phase 2CompletedNCT01620515

Nymox Corporation141 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Prostate Cancer

Interventions

NX-1207 2.5 mgDRUG

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

NX-1207 15 mgDRUG

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

Eligibility

Sex: MALEMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (23)

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline to 45 days post-treatment

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.

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.

Time frame: Baseline to 60 days post-treatment

Secondary Outcomes

Change in tumor grade in the region of the baseline prostate cancer

Time frame: Baseline to 45 days post-treatment

Change in tumor volume in the region of the baseline prostate cancer

Time frame: Baseline to 45 days post-treatment

Change in tumor grade for the whole prostate

Time frame: Baseline to 45 days post-treatment

Change in tumor volume in the whole prostate

Time frame: Baseline to 45 days post-treatment

Data from ClinicalTrials.gov

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