A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer
A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer
RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have relapsed prostate cancer following radiation therapy or radical prostatectomy.
OBJECTIVES:
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.
DISEASE CHARACTERISTICS:
Diagnosis of clinically localized adenocarcinoma of the prostate
Received prior primary treatment with definitive radiotherapy (at least 5,500 cGy) OR radical prostatectomy
Biochemical relapse within 5 years after prior primary therapy, defined as 1 of the following:
PSA no greater than 10 ng/mL
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 6 months since prior adjuvant or neoadjuvant hormonal therapy
Radiotherapy
Surgery