Exisulind Versus Placebo After Surgical Removal of the Prostate

NCT ID: NCT00166426

Last Updated: 2009-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2008-05-31

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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Exisulind

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Males 18 years of age or older with prostate cancer treated primarily by radical prostatectomy and randomized within 45 days after surgery may be eligible for enrollment into this protocol. Participants cannot have had hormonal therapy, cryotherapy, thermotherapy, or radiotherapy prior to entering the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

OSI Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Principal Investigators

Bradley C. Leibovich, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

526-02

Identifier Type: -

Identifier Source: org_study_id