Exisulind Prior to Radical Prostatectomy

Phase 2

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00166478
• Lead Sponsor: Mayo Clinic

Brief Summary

This trial will compare no treatment to exisulind therapy. Patients enrolled on the treatment arm will begin treatment 4 weeks prior to the scheduled date of surgical removal of the prostate and will take 375 mg by mouth daily for the 4 weeks prior to radical prostatectomy. Participants will be followed for total of 2 months from the time of starting study drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-26
• Last Update Posted: 2010-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
4 week changes in apoptosis biomarkers

Secondary Outcome Measures

Name	Time	Method
4 week changes in surrogate endpoint biomarkers

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States