Exisulind Prior to Radical Prostatectomy

This study is currently recruiting participants.

Verified by Mayo Clinic, September 2005

First Received: September 12, 2005 No Changes Posted

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00166478

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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Sulindac sulfone

U.S. FDA Resources

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

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

Estimated Enrollment:	130
Study Start Date:	April 2002

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	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jane E Smith 507-284-3369
Principal Investigator: Bradley C Leibovich, M.D.

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Bradley C. Leibovich, M.D.

Mayo Clinic

More Information

No publications provided

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009