R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed localized adenocarcinoma of the prostate (from a pre-operative core biopsy, surgical specimen, or post-therapy core biopsy)
• Gleason score 5-10 at diagnosis (the highest score is used if multiple scores are available)
• Must have undergone 1 of the following curative treatment strategies:
• * Radical prostatectomy
• * Not a candidate for radiotherapy
• * Radical prostatectomy followed by radiotherapy at the time of surgery or any time thereafter
• * Radiotherapy of the prostate and/or surrounding structures by external beam radiotherapy (EBRT), brachytherapy (BT), or a combination of EBRT and BT
• Must have 3 consecutive rising prostate-specific antigen (PSA) measurements OR meets slope criteria
• Biochemical failure, meeting 1 of the following criteria:
• * PSA at least 0.2 ng/mL post radical prostatectomy
• * PSA greater than 1.5 ng/mL after radiotherapy or appropriate calculated slope
• Testosterone at least 100 ng/mL
• No rise in PSA with concurrent clinically active prostatitis
• No metastatic prostate cancer
• PSA no greater than 20.0 ng/mL
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• Karnofsky 70-100%
• Life expectancy
• Not specified
• Hematopoietic
• WBC at least 2,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 10 g/dL
• Hepatic
• Bilirubin no greater than 1.5 mg/dL
• AST or ALT no greater than 2 times upper limit of normal
• Renal
• Creatinine no greater than 2.0 mg/dL
• Cardiovascular
• No uncontrolled cardiac conditions
• No New York Heart Association class III or IV heart disease
• Gastrointestinal
• No active ulcer disease diagnosed within the past 3 months
• No upper gastrointestinal bleed requiring a transfusion within the past 3 years
• No non-steroidal anti-inflammatory drug (NSAID)-associated ulcers within the past 5 years
• Other
• No known hypersensitivity to NSAIDs, including COX-2-specific inhibitors (e.g., celecoxib or rofecoxib)
• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
• No active systemic infections
• No other serious uncontrolled medical condition
• No dementia or altered mental status
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No concurrent biologic therapy
• Chemotherapy
• More than 5 years since prior cytotoxic chemotherapy for other malignant disease
• No prior cytotoxic chemotherapy for prostate cancer
• No concurrent chemotherapy
• Endocrine therapy
• More than 9 months since prior androgen-deprivation therapy other than as cytoreductive therapy (neoadjuvantly or adjuvantly for less than 9 months) with the intent to cure
• More than 3 months since prior cyproterone, finasteride, diethylstilbestrol, megestrol, or other hormonally active (antiandrogen or antiprostate) therapies
• Radiotherapy
• See Disease Characteristics
• No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other radioisotope materials for palliative intent or metastasis intervention
• Concurrent iodine I 125 or palladium Pd 103 for primary brachytherapy with curative intent allowed
• Surgery
• See Disease Characteristics
• More than 8 weeks since prior major surgery and recovered
• No prior orchiectomy
• Other
• More than 1 month since prior PC-SPES
• More than 1 month since prior investigational agents or devices (6 months for other investigational therapy for prostate cancer)
• No prior bisphosphonates (e.g., pamidronate, alendronate, or clodronate) for palliative intent or metastasis intervention
• At least 2 months since prior chronic non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2)-specific inhibitors (e.g., celecoxib or rofecoxib), administered for more than 7 days per month
• No concurrent CYP2C9 inhibitor or substrates, including but not limited to the following:
• * Phenytoin
• * Fluvastatin
• * Amiodarone
• * Fluconazole
• * Acenocoumarol
• * Diclofenac
• No concurrent ketoconazole
• No concurrent antiretroviral therapy for HIV-positive patients
• Concurrent cardioprotective aspirin up to 100 mg once daily allowed