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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00166478 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostatic Neoplasms |
Drug: Exisulind Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective Controlled Phase II Study of Preoperative Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Jane E Smith 507-284-3369 | |
Principal Investigator: Bradley C Leibovich, M.D. |
Principal Investigator: | Bradley C. Leibovich, M.D. | Mayo Clinic |
Study ID Numbers: | 2297-01, N01-CN-75017 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00166478 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anticarcinogenic Agents Anti-Inflammatory Agents Genital Neoplasms, Male Prostatic Diseases Cyclooxygenase Inhibitors Urogenital Neoplasms Genital Diseases, Male Sulindac sulfone |
Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Sulindac Analgesics Antirheumatic Agents Prostatic Neoplasms |
Anticarcinogenic Agents Anti-Inflammatory Agents Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Cyclooxygenase Inhibitors Enzyme Inhibitors Genital Diseases, Male Protective Agents Sulindac sulfone Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Prostatic Neoplasms Central Nervous System Agents |