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Trial record 1 of 1 for:    NCT02840162
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Pre-Prostatectomy Celecoxib or Placebo

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ClinicalTrials.gov Identifier: NCT02840162
Recruitment Status : Terminated (Drug safety concerns)
First Posted : July 21, 2016
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Tom Beer, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE May 2001
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
Apoptosis Index, defined as the percent positive staining cells [ Time Frame: approximately 4 weeks of treatment ]
Percent positively staining cells with a minimum of 1000 total cells counted. Descriptive statistics will be conducted. The apoptotic index will be reported with 95% confidence intervals.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • Prostaglandin and Androgen Receptor Levels [ Time Frame: approximately 4 weeks of treatment ]
    Descriptive statistical analysis will be conducted. The estimates will be reported with 95% confidence intervals.
  • Percent Change in Median PSA Values, pre- and postoperatively [ Time Frame: approximately 4 weeks of treatment ]
    Pre- and postoperative PSA will be collected. Descriptive statistics will be conducted, comparing preoperative PSA level to postoperative level.
  • Perioperative Analgesic Use, using morphine equivalents [ Time Frame: Prostatectomy to discharge from hospital, no more than 30 days post prostatectomy ]
    Descriptive statistical analysis will be conducted. The estimate will be calculated using morphine equivalents dividend by length of hospital stay and reported with 95% confidence intervals.
  • Surgical Complications, defined as incidence of adverse events determined to be related to surgery graded by NCI CTCAE version 2.0 [ Time Frame: Intraoperatively to 30 days postoperatively ]
    Intraoperative and post surgical complications will be collected and reported.
  • Incidence of Adverse Events, graded by NCI CTCAE version 2.0 [ Time Frame: From start of treatment to 30 days post prostatectomy ]
    Descriptive statistical analysis will be conducted
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • Prostaglandin and Androgen Receptor Levels [ Time Frame: approximately 4 weeks of treatment ]
    Descriptive statistical analysis will be conducted. The estimates will be reported with 95% confidence intervals.
  • Percent change in median PSA values pre- and post-operatively [ Time Frame: approximately 4 weeks of treatment ]
    Pre- and post-operative PSA will be collected. Descriptive statistics will be conducted, comparing pre-operative PSA level to post-operative level.
  • Peri-operative Analgesic Use, using morphine equivalents [ Time Frame: Prostatectomy to discharge from hospital, no more than 30 days post prostatectomy ]
    Descriptive statistical analysis will be conducted. The estimate will be calculated using morphine equivalents dividend by length of hospital stay and reported with 95% confidence intervals.
  • Surgical Complications, defined as incidence of adverse events determined to be related to surgery graded by NCI CTCAE version 2.0 [ Time Frame: Intra-operatively to 30-days post-operatively ]
    Intra-operative and post-surgical complications will be collected and reported.
  • Incidence of adverse events graded by NCI CTCAE [ Time Frame: From start of treatment to 30 days post prostatectomy ]
    Descriptive statistical analysis will be conducted
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, MD OHSU 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