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

Johns Hopkins Medicine

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: celecoxib; Drug: Placebos

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00022399

P30CA006973 (U.S. NIH Grant/Contract)

P50CA058236 (U.S. NIH Grant/Contract)

NCI-N01-95129

00-03-08-01 (Other Identifier)

J0007

NCI-P01-0186

CDR0000068812

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 73 patients

Sex: Male

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

73 participants in 2 patient groups, including a placebo group

Celecoxib

Experimental group

Description:

Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.

Treatment:

Drug: celecoxib

Placebo-control

Placebo Comparator group

Description:

Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.

Treatment:

Drug: Placebos