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 Prior to Radical Prostatectomy

This study has been completed.
Information provided by:
Mayo Clinic Identifier:
First received: September 12, 2005
Last updated: January 26, 2010
Last verified: January 2010

September 12, 2005
January 26, 2010
April 2002
October 2007   (final data collection date for primary outcome measure)
4 week changes in apoptosis biomarkers
Same as current
Complete list of historical versions of study NCT00166478 on Archive Site
4 week changes in surrogate endpoint biomarkers
Same as current
Not Provided
Not Provided
Exisulind Prior to Radical Prostatectomy
A Prospective Controlled Phase II Study of Preoperative Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis

This trial will compare no treatment to exisulind therapy. Patients enrolled on the treatment arm will begin treatment 4 weeks prior to the scheduled date of surgical removal of the prostate and will take 375 mg by mouth daily for the 4 weeks prior to radical prostatectomy. Participants will be followed for total of 2 months from the time of starting study drug.

Not Provided
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Neoplasms
Drug: Exisulind Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2007
October 2007   (final data collection date for primary outcome measure)

Males 40 years of age and older with prostate cancer who are scheduled to undergo surgical removal of the prostate at Mayo Clinic Rochester, Mayo Clinic Jacksonville, or Mayo Clinic Arizona may be eligible for this protocol.

40 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
2297-01, N01-CN-75017
Not Provided
Not Provided
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Bradley C. Leibovich, M.D. Mayo Clinic
Mayo Clinic
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP