Prostatic Neoplasms
Conditions
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.
Interventions
DRUGExisulind
Sponsors
OSI Pharmaceuticals
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed