Exisulind Versus Placebo After Surgical Removal of the Prostate

Overview

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.

Full Title of Study: “Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double
  • Study Primary Completion Date: May 2007

Interventions

  • Drug: Exisulind

Clinical Trial Outcome Measures

Primary Measures

  • Assess efficacy of drug vs placebo regarding overall rate of biochemical progression
  • Assess the efficacy of drug vs placebo regarding time to biochemical progression
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • OSI Pharmaceuticals
  • Overall Official(s)
    • Bradley C. Leibovich, M.D., Principal Investigator, Mayo Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.