Exisulind Prior to Radical Prostatectomy

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Drug: Exisulind Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00166478

2297-01

N01-CN-75017

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)