Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
- Registration Number
- NCT01620515
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 141
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NX-1207 2.5 mg NX-1207 2.5 mg - NX-1207 15 mg NX-1207 15 mg -
- Primary Outcome Measures
Name Time Method Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected. 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.
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. 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
Name Time Method Change in tumor grade in the region of the baseline prostate cancer Baseline to 45 days post-treatment Change in tumor volume in the region of the baseline prostate cancer Baseline to 45 days post-treatment Change in tumor grade for the whole prostate Baseline to 45 days post-treatment Change in tumor volume in the whole prostate Baseline to 45 days post-treatment
Trial Locations
- Locations (1)
For information concerning this clinical site, please contact Nymox at 800-936-9669.
🇺🇸Salt Lake City, Utah, United States