Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
Brief summary
RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer. PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer.
Detailed description
OBJECTIVES: * Compare biomarker modulation (prostaglandin levels) in tissue samples of patients with localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by prostatectomy. * Compare the effect of these regimens on angiogenic factors within the prostate in these patients. * Determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these patients. * Compare the toxicity profiles of these regimens in these patients. * Compare the compliance of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral neoadjuvant celecoxib twice daily. * Arm II: Patients receive oral neoadjuvant placebo twice daily. Treatment in both arms continues for at least 4 weeks followed by prostatectomy. Patients are followed within 1 month and then at 3 months. PROJECTED ACCRUAL: A total of 60-70 patients (at least 30 per arm) will be accrued for this study.
Interventions
400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States