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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00022399
Date of registration: 10/08/2001
Primary sponsor: Sidney Kimmel Comprehensive Cancer Center
Public title: Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
Scientific 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
Date of first enrolment: September 2001
Target sample size:
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention  
Countries of recruitment
United States
Name:   Michael A. Carducci, MD
Affiliation:  Sidney Kimmel Comprehensive Cancer Center
Key inclusion & exclusion criteria


- 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


- 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

- 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

- No aspirin (100 mg/day) within 1 week prior to surgery

- No concurrent addition of vitamins or herbal supplements

Age minimum: 18 Years
Age maximum: N/A
Gender: Male
Health Condition(s) or Problem(s) studied
Prostate Cancer
Drug: celecoxib
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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