Exisulind Versus Placebo After Surgical Removal of the Prostate
This study has been completed.
Information provided by:
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
||Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy
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:
| Study Start Date:
| Study Completion Date:
| 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:
|Accepts Healthy Volunteers:
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00166426
|Rochester, Minnesota, United States, 55905 |
||Bradley C. Leibovich, M.D.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
||November 13, 2009
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents