Back to resultsExisulind Versus Placebo After Surgical Removal of the Prostate
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exisulind
Sponsored by
About this trial
This is an interventional prevention trial for Prostatic Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00166426
First Posted
September 12, 2005
Last Updated
November 13, 2009
Sponsor
Mayo Clinic
Collaborators
OSI Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00166426
Brief Title
Exisulind Versus Placebo After Surgical Removal of the Prostate
Official Title
Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
OSI Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Exisulind
Primary Outcome Measure Information:
Title
Assess efficacy of drug vs placebo regarding overall rate of biochemical progression
Title
Assess the efficacy of drug vs placebo regarding time to biochemical progression
Title
Assess efficacy of drug vs placebo regarding overall rate of clinical progression
Title
Assess efficacy of drug vs placebo regarding time to clinical progression
Title
Assess efficacy of drug vs placebo regarding cancer specific survival
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley C. Leibovich, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exisulind Versus Placebo After Surgical Removal of the Prostate
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