R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer
Eligibility Criteria
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
Sites / Locations
- Urology Centers of Alabama
- Alaska Clinical Research Center, LLC
- Urology Associates Of Central California
- Orange County Urology Associates
- South Orange County Hematology-Oncology Associates
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Atlantic Urology Medical Group
- Jonsson Comprehensive Cancer Center, UCLA
- San Diego Urological Medical Group
- Coastal Medical Research Group, Incorporated
- Urology Associates - Research
- Walter Reed Army Medical Center
- South Florida Medical Research
- Lynn Regional Cancer Center West
- 21st Century Oncology - Fort Myers
- UroSearch - Ocala
- Rice, Lake and Harper Urology, LLC
- North Idaho Urology
- Cancer Care Specialists of Central Illinois, S.C. - Decatur
- Decatur Memorial Hospital Cancer Care Institute
- Evanston Northwestern Health Care - Evanston Hospital
- Northeast Indiana Research, LLC
- Cancer Center at Lexington Clinic
- Regional Urology, L.L.C.
- St. Agnes Cancer Center
- Drs. Werner, Murdock and Francis, P.A., Urology Associates
- Lakeside Urology, P.C.
- Mallinckrodt Institute of Radiology
- Lawrenceville Urology
- Center for Urologic Care
- Veterans Affairs Medical Center - Albany
- AccuMed Research Associates
- Staten Island Urologic Oncology
- Urology Center
- Charles M. Barrett Cancer Center at University Hospital
- Ireland Cancer Center
- Urological Associates, Incorporated
- Oregon Urology Specialists
- Center for Urologic Care
- Urological Associates of Lancaster, Ltd.
- Center of Urologic Care of Berks County
- Rhode Island Hospital
- University Urological Research Institute
- Grand Strand Urology LLP
- University of Tennessee - Graduate School of Medicine
- Urology Associates
- Urology Associates of North Texas
- Urology Clinics of North Texas
- Baylor University Medical Center
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Urology Consultants, P.A.
- Center for Cancer Prevention and Care at Scott and White Clinic
- Salt Lake Research
- Vermont Cancer Center at University of Vermont
- Northwest Hospital and Medical Center
- Highline Hospital Campus
- University of Wisconsin Comprehensive Cancer Center