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

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.

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.

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