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

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ClinicalTrials.gov Identifier: NCT00022399
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 21, 2011
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: celecoxib Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation
Study Start Date : September 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Celecoxib
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • 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


  • Bilirubin less than 1.5 mg/dL
  • AST/ALT less than 1.5 times upper limit of normal
  • No viral hepatitis


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min


  • 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


Biologic therapy:

  • No prior immunologic therapy for prostate cancer


  • 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


  • At least 4 weeks since prior radiotherapy to the pelvis or surrounding tissues and recovered


  • See Disease Characteristics
  • At least 4 weeks since prior major surgery and recovered


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022399

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael A. Carducci, MD Sidney Kimmel Comprehensive Cancer Center

ClinicalTrials.gov Identifier: NCT00022399     History of Changes
Other Study ID Numbers: CDR0000068812
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: October 2004

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents