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Exisulind Versus Placebo After Surgical Removal of the Prostate

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.
ClinicalTrials.gov Identifier: NCT00166426
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 16, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Exisulind Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Study Start Date : February 2003
Primary Completion Date : May 2007
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Assess efficacy of drug vs placebo regarding overall rate of biochemical progression
  2. Assess the efficacy of drug vs placebo regarding time to biochemical progression
  3. Assess efficacy of drug vs placebo regarding overall rate of clinical progression
  4. Assess efficacy of drug vs placebo regarding time to clinical progression
  5. Assess efficacy of drug vs placebo regarding cancer specific survival

Eligibility Criteria

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 Posted: September 14, 2005    Key Record Dates
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