Exisulind Versus Placebo After Surgical Removal of the Prostate

Prostatic Neoplasms Clinical Trial

Official title:

Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166426
• Other study ID #: 526-02
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: November 13, 2009
• Start date: February 2003
• Est. completion date: May 2008

Study information

• Verified date: November 2009
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Exisulind

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	OSI Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess efficacy of drug vs placebo regarding overall rate of biochemical progression
Primary	Assess the efficacy of drug vs placebo regarding time to biochemical progression
Primary	Assess efficacy of drug vs placebo regarding overall rate of clinical progression
Primary	Assess efficacy of drug vs placebo regarding time to clinical progression
Primary	Assess efficacy of drug vs placebo regarding cancer specific survival