A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer
- Determine the effect of celecoxib on prostate-specific antigen (PSA) levels in patients
with prostate cancer in biochemical relapse after prior definitive radiotherapy or
- Compare the PSA doubling times in patients treated with this drug vs historical
- Compare the PSA doubling times in patients treated with this drug vs pretreatment PSA
- Determine the time to clinical recurrence in patients treated with this drug.
OUTLINE: Patients receive oral celecoxib twice daily. Treatment continues for 5 years in the
absence of disease progression. Patients may continue treatment beyond 5 years at the
discretion of the treating physician.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of COX-2 inhibitors on PSA level
To study the effect of COX-2 inhibitors on PSA level in patients who have only biochemical relapse after definitive radiation therapy or surgery for prostate cancer. In particular, to study the effect of celecoxib on PSA levels and PSA doubling times as compared to 1) historical controls (known and well-described median PSA doubling times of 9 months), and 2) pre-treatment PSA values and doubling times.
Raj S. Pruthi, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|