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Exisulind Versus Placebo After Surgical Removal of the Prostate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00166426
First Posted: September 14, 2005
Last Update Posted: November 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
OSI Pharmaceuticals
Information provided by:
Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Prostatic Neoplasms Drug: Exisulind Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome 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

Estimated Enrollment: 240
Study Start Date: February 2003
Study Completion Date: May 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166426


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
OSI Pharmaceuticals
Investigators
Principal Investigator: Bradley C. Leibovich, M.D. Mayo Clinic
  More Information

ClinicalTrials.gov Identifier: NCT00166426     History of Changes
Other Study ID Numbers: 526-02
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: November 16, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sulindac sulfone
Sulindac
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents