Pre-Prostatectomy Celecoxib or Placebo

NCT02840162

Last updated date
Study Location
Portland VA Medical Center
Portland, Oregon, 97207, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adenocarcinoma of the Prostate, Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Adenocarcinoma of the Prostate, Prostate CancerPre-Prostatectomy Celecoxib or Placebo
NCT02840162
  1. Portland, Oregon
  2. Portland, Oregon
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pre-Prostatectomy Celecoxib or Placebo
Official Title  ICMJE Randomized Study of Pre-Prostatectomy Celecoxib or Placebo
Brief Summary 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

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenocarcinoma of the Prostate
  • Prostate Cancer
Intervention  ICMJE
  • Drug: Celecoxib
    Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition
    Other Names:
    • Celebrex
    • 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]
    • Benzenesulfonamide
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Celecoxib
    Treated patients will receive 4 weeks of celecoxib at 400 mg twice daily by mouth
    Intervention: Drug: Celecoxib
  • Placebo Comparator: Placebo
    Control patients will receive a suitable placebo for 4 weeks, twice daily by mouth
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 18, 2016)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840162
Other Study ID Numbers  ICMJE IRB00001004
HOR-01019-L ( Other Identifier: OHSU Knight Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tom Beer, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Tomasz M Beer, MDOHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP