Exisulind Versus Placebo After Surgical Removal of the Prostate

Phase 2

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00166426
• Lead Sponsor: Mayo Clinic

Brief Summary

This is a study in which patients with prostate cancer treated by surgical removal of the prostate and considered to be at risk for prostate cancer recurrence will receive Exisulind 250 mg twice a day or placebo twice a day for two years.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2007-05
• Study Completion: 2008-05
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-13
• Last Update Posted: 2009-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess efficacy of drug vs placebo regarding overall rate of clinical progression
Assess efficacy of drug vs placebo regarding time to clinical progression
Assess efficacy of drug vs placebo regarding cancer specific survival
Assess efficacy of drug vs placebo regarding overall rate of biochemical progression
Assess the efficacy of drug vs placebo regarding time to biochemical progression

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States