Exisulind Versus Placebo After Surgical Removal of the Prostate

Mayo Clinic240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

240

Conditions

Prostatic Neoplasms

Interventions

ExisulindDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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