Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-Prostatectomy Celecoxib or Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Prostate Cancer Drug: Celecoxib Drug: Placebo Phase 2

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study of Pre-Prostatectomy Celecoxib or Placebo
Study Start Date : May 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Active Comparator: Celecoxib
Treated patients will receive 4 weeks of celecoxib at 400 mg twice daily by mouth
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

Placebo Comparator: Placebo
Control patients will receive a suitable placebo for 4 weeks, twice daily by mouth
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840162


Locations
Layout table for location information
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97207
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Pfizer
Investigators
Layout table for investigator information
Principal Investigator: Tomasz M Beer, MD OHSU Knight Cancer Institute

Layout table for additonal information
Responsible Party: Tom Beer, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT02840162     History of Changes
Other Study ID Numbers: IRB00001004
HOR-01019-L ( Other Identifier: OHSU Knight Cancer Institute )
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Tom Beer, OHSU Knight Cancer Institute:
prostate cancer
NSAIDs
chemoprevention
celecoxib
COX-2 inhibitors
Additional relevant MeSH terms:
Layout table for MeSH terms
Celecoxib
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Benzenesulfonamide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Carbonic Anhydrase Inhibitors