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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: NX-1207 2.5 mg
* Drug: NX-1207 15 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Active Surveillance<br>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<br> | Drug: NX-1207 2.5 mg<br>* A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.<br>|
| Experimental: NX-1207 15 mg<br> | Drug: NX-1207 15 mg<br>* A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline to 60 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Prostate Cancer, Localized Prostate Cancer, T1c Prostate Cancer, Focal Therapy, NX-1207