Prostate Cancer
Conditions
Keywords
Prostate, Prostate Cancer, Localized Prostate Cancer, T1c Prostate Cancer, Focal Therapy, NX-1207
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.
Interventions
DRUGNX-1207 2.5 mg
A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
DRUGNX-1207 15 mg
A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.
Sponsors
Nymox Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
United States
Outcome results
None listed