Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
Prostate Cancer
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed localized adenocarcinoma of the prostate with one or more of the following: Gleason sum at least 7 Prostate-specific antigen (PSA) at least 15 ng/mL Clinical stage T2b or T2c (stage II) Any combination of PSA, clinical stage, or Gleason sum with an estimated risk of capsular penetration greater than 45% At least 3 positive core biopsies Planned radical prostatectomy No metastatic disease secondary to prostate cancer PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 9 g/dL No history of bleeding disorders Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 1.5 times upper limit of normal No viral hepatitis Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Other: No history of hypersensitivity and/or adverse reactions to salicylates No allergy to sulfa-containing medications No other active malignancy within the past 5 years except superficial bladder cancer or nonmelanoma skin cancer No medical or psychiatric problem that would preclude study participation No active infection HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunologic therapy for prostate cancer Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: No prior androgen ablation for prostate cancer At least 4 weeks since prior hormonal therapy and recovered At least 30 days since prior chronic use (more than 3 times per week for more than 2 weeks) of glucocorticoids No concurrent glucocorticoids Radiotherapy: At least 4 weeks since prior radiotherapy to the pelvis or surrounding tissues and recovered Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered Other: No prior investigational therapy for prostate cancer No prior or concurrent chronic anticoagulants No prior cyclo-oxygenase-2 inhibitor therapy (e.g., rofecoxib or celecoxib) At least 4 weeks since prior initiation of vitamins (except multivitamin) or herbs with known effects on prostate function (PSA) At least 30 days since prior chronic use (more than 3 times per week for more than 2 weeks) of aspirin (greater than 100 mg/day) or non-steroidal anti-inflammatory drugs (NSAIDs) At least 24 hours since prior use and no concurrent use of any of the following: Over-the-counter (OTC) or prescription products containing aspirin or NSAIDs; OTC products containing bismuth subsalicylate, sodium salicylate, and/or magnesium salicylate; choline salicylate; ranitidine; cimetidine; famotidine; or lansoprazole No aspirin (100 mg/day) within 1 week prior to surgery No concurrent addition of vitamins or herbal supplements
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Celecoxib
Placebo-control
Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.
Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.