Exisulind Versus Placebo After Surgical Removal of the Prostate

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Drug: Exisulind

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00166426

526-02

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind