drugset / Trial / NCT01620515
Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-02-21
- Primary completion
- 2015-10-21
- Completion
- 2015-10-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FEXAPOTIDE | Protein / enzyme biologic | 2.5 mg | Other |
| Subject | FEXAPOTIDE | Protein / enzyme biologic | 15 mg | Other |