NCT01705652

Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients

Phase II Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients Undergoing Surgery or Radiation Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to (1) to determine the rate of PSA decline (the number declining). Tissue will be obtained for ancillary studies and (2) to determine the number of patients with a PSA decline to \<1.0 ng/ml at 3 months in patients receiving Nexrutine® with standard radiation therapy. The Secondary Objective is to confirm the tolerability of this regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of Nexrutine®. Molecular response is defined as changes in the molecular pathways.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Nexrutine	Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-10-12
• Last updated: 2015-06-11
• Results posted: 2015-06-11

Locations

1 site across 1 country: United States