Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: celecoxib
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br>Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy. | Drug: celecoxib<br>* 400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.<br>* Other names: celebrex;|
| Placebo Comparator: Placebo-control<br>Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy. | Drug: Placebos<br>* Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate