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

NCT01705652 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-06-11

Study results available
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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

Interventions

DRUG

Nexrutine

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

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Gregory P. Swanson, MD · The University of Texas Health Science Center at San Antonio

  • William E. Jones, III, MD · The University of Texas Health Science Center at San Antonio and ALM VA Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01705652 on ClinicalTrials.gov