NCT01620515

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Nymox Corporation · Industry
• Sex: Male
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	NX-1207 2.5 mg	A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
DRUG	NX-1207 15 mg	A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.

Timeline

• Start date: 2012-02-21
• Primary completion: 2015-10-21
• Completion: 2015-10-21
• First posted: 2012-06-15
• Last updated: 2017-03-10

Locations

23 sites across 1 country: United States