Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Prevention, Treatment Completed 18 and over NCI JHOC-J0007 JHOC-00030801, NCI-N01-95129, NCI-P01-0186, NCT00022399, J0007

Special Category: SPORE trial

Objectives

1. Compare biomarker modulation (prostaglandin levels) in tissue samples of patients with localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by prostatectomy.
2. Compare the effect of these regimens on angiogenic factors within the prostate in these patients.
3. Determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these patients.
4. Compare the toxicity profiles of these regimens in these patients.
5. Compare the compliance of patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

A total of 60-70 patients (at least 30 per arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Michael Carducci, MD, Protocol chair		Ph: 410-614-3977 Email: carducci@welchlink.welch.jhu.edu

Registry Information
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
Trial Start Date		2001-09-04
Registered in ClinicalTrials.gov		NCT00022399
Date Submitted to PDQ		2001-06-14
Information Last Verified		2004-10-18
NCI Grant/Contract Number		CA06973, CA58236, CN95129

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