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Exisulind Versus Placebo After Surgical Removal of the Prostate

This study has been completed.
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166426
First received: September 12, 2005
Last updated: November 13, 2009
Last verified: November 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00166426     History of Changes
Other Study ID Numbers: 526-02
Study First Received: September 12, 2005
Last Updated: November 13, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Sulindac sulfone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013