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

February 6, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Celecoxib
Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.
Drug: celecoxib
400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
Other Names:
  • celebrex
Placebo Comparator: Placebo-control
Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.
Drug: Placebos
Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael A. Carducci, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 25, 2002

Primary Completion (Actual)

January 31, 2005

Study Completion (Actual)

January 31, 2005

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0007
  • P30CA006973 (U.S. NIH Grant/Contract)
  • P50CA058236 (U.S. NIH Grant/Contract)
  • CDR0000068812
  • 00-03-08-01 (Other Identifier: JHM IRB)
  • NCI-N01-95129
  • NCI-P01-0186

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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