Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exisulind Versus Placebo After Surgical Removal of the Prostate

This study has been completed.
OSI Pharmaceuticals
Information provided by:
Mayo Clinic Identifier:
First received: September 12, 2005
Last updated: November 13, 2009
Last verified: November 2009

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:

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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00166426

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

No publications provided 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:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on March 03, 2015