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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
No
United States: Food and Drug Administration
NX03-0040
NCT01620515
June 2012
May 2013
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