Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UNC Lineberger Comprehensive Cancer Center
With
National Cancer Institute (NCI)
OBJECTIVES:
* Determine the effect of celecoxib on prostate-specific antigen (PSA) levels in patients with prostate cancer in biochemical relapse after prior definitive radiotherapy or radical prostatectomy.
* Compare the PSA doubling times in patients treated with this drug vs historical controls.
* Compare the PSA doubling times in patients treated with this drug vs pretreatment PSA values.
* 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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Diagnosis of clinically localized adenocarcinoma of the prostate
* T1 or T2 disease
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:
* Detectable and rising prostate-specific antigen (PSA) after surgery (at least 2 values above the residual cancer detection limit of the assay)
* PSA at least 2 values above 1 ng/mL OR at least 3 rising values at any level after radiotherapy
PSA no greater than 10 ng/mL
PATIENT CHARACTERISTICS:
Age
Not specified
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
ALT no greater than 2.5 times upper limit of normal
Renal
Creatinine normal
Other
No allergy to cyclooxygenase-2 inhibitors, aspirin, nonsteroidal anti-inflammatory drugs, or sulfa drugs
No untreated peptic ulcer disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
No prior chemotherapy
Endocrine therapy
More than 6 months since prior adjuvant or neoadjuvant hormonal therapy
* Duration of prior adjuvant or neoadjuvant hormonal therapy must have been no more than 6 months
Radiotherapy
See Disease Characteristics
Prior salvage radiotherapy after prostatectomy allowed
