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