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

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