Text Size

Exisulind Prior to Radical Prostatectomy

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166478
First received: September 12, 2005
Last updated: January 26, 2010
Last verified: January 2010
History of Changes
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Controlled Phase II Study of Preoperative Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 4 week changes in apoptosis biomarkers

Secondary Outcome Measures:
  • 4 week changes in surrogate endpoint biomarkers

Enrollment: 130
Study Start Date: April 2002
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166478

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Bradley C. Leibovich, M.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00166478     History of Changes
Other Study ID Numbers: 2297-01, N01-CN-75017
Study First Received: September 12, 2005
Last Updated: January 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Sulindac sulfone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
 Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 18, 2013