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Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

Trial Information

Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Assess efficacy of drug vs placebo regarding overall rate of biochemical progression

Principal Investigator

Bradley C. Leibovich, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

526-02

NCT ID:

NCT00166426

Start Date:

February 2003

Completion Date:

May 2008

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905