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Exisulind Prior to Radical Prostatectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00166478
First Posted: September 14, 2005
Last Update Posted: January 28, 2010
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:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
September 12, 2005
September 14, 2005
January 28, 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 ClinicalTrials.gov 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
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
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.
Sexes Eligible for Study: Male
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00166478
2297-01
N01-CN-75017
Not Provided
Not Provided
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