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