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Pre-Prostatectomy Celecoxib or Placebo

NCT ID: NCT02840162

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2011-05-31

Brief Summary

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This study will seek to determine if the downstream effects of cyclooxygenase-2 (COX-2) inhibition suggested by preclinical systems occur in human prostate cancer. To answer this question, men who have chosen prostatectomy will be randomly assigned to preoperative treatment with celecoxib or placebo for four weeks. Carefully collected tumor, premalignant, and benign prostate tissue will then be examined for apoptosis, androgen receptor and prostaglandin E2 levels. Tumor COX-2 expression will be correlated with observed treatment effects. The data generated by this study will serve as a foundation for the development of COX-2 targeted therapies for prostate cancer, will provide preliminary evidence for larger scale clinical trials aimed at treatment and prevention of prostate cancer, and will validate current preclinical models used to study COX-2 in prostate cancer.

Detailed Description

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PRIMARY OBJECTIVE

I. To determine if COX-2 inhibition with celecoxib significantly increases apoptosis in human adenocarcinoma of the prostate.

SECONDARY OBJECTIVES

I. To determine if COX-2 inhibition with celecoxib reduces levels of Prostaglandin E2 and androgen receptor in fresh tumor tissue collected at prostatectomy

II. To collect pre- and postoperative serum Prostate Specific Antigen (PSA) for exploratory analyses

III. To determine the effect of celecoxib on adverse effects, perioperative surgical complications and post surgery analgesic use

Conditions

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Adenocarcinoma of the Prostate Prostate Cancer

Keywords

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prostate cancer NSAIDs chemoprevention celecoxib COX-2 inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Celecoxib

Treated patients will receive 4 weeks of celecoxib at 400 mg twice daily by mouth

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition

Placebo

Control patients will receive a suitable placebo for 4 weeks, twice daily by mouth

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Celecoxib

Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Celebrex 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] Benzenesulfonamide

Eligibility Criteria

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Inclusion Criteria

* Histopathologically or cytologically proven adenocarcinoma of the prostate and planned prostatectomy
* Age \>= 18
* Performance status (ECOG \<= 2)
* Hemoglobin \> 10 g/dL (within 4 weeks)
* Creatinine \<= 1.5 mg/dL
* Signed informed patient consent

Exclusion Criteria

* Other preoperative or prior treatment directed at prostate cancer
* Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* Use of non-steroidal anti-inflammatory agents within seven days of celecoxib treatment
* Hypersensitivity to celecoxib
* A history of asthma, urticaria, or anaphylaxis precipitated by an NSAID
* History of significant upper gastrointestinal bleeding or active peptic ulcer disease
* Current treatment with anticoagulants
* Allergy to sulfonamide
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Tom Beer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomasz M Beer, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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Portland VA Medical Center

Portland, Oregon, United States

Site Status

OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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HOR-01019-L

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00001004

Identifier Type: -

Identifier Source: org_study_id