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Pre-Prostatectomy Celecoxib or Placebo

Primary Purpose

Adenocarcinoma of the Prostate, Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Placebo
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring prostate cancer, NSAIDs, chemoprevention, celecoxib, COX-2 inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Portland VA Medical Center
  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Celecoxib

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Apoptosis Index, defined as the percent positive staining cells
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

Prostaglandin and Androgen Receptor Levels
Descriptive statistical analysis will be conducted. The estimates will be reported with 95% confidence intervals.
Percent Change in Median PSA Values, pre- and postoperatively
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
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
Intraoperative and post surgical complications will be collected and reported.
Incidence of Adverse Events, graded by NCI CTCAE version 2.0
Descriptive statistical analysis will be conducted

Full Information

First Posted
July 15, 2016
Last Updated
April 26, 2017
Sponsor
OHSU Knight Cancer Institute
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02840162
Brief Title
Pre-Prostatectomy Celecoxib or Placebo
Official Title
Randomized Study of Pre-Prostatectomy Celecoxib or Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Drug safety concerns
Study Start Date
May 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Prostate Cancer
Keywords
prostate cancer, NSAIDs, chemoprevention, celecoxib, COX-2 inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib
Arm Type
Active Comparator
Arm Description
Treated patients will receive 4 weeks of celecoxib at 400 mg twice daily by mouth
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control patients will receive a suitable placebo for 4 weeks, twice daily by mouth
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl], Benzenesulfonamide
Intervention Description
Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Apoptosis Index, defined as the percent positive staining cells
Description
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.
Time Frame
approximately 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Prostaglandin and Androgen Receptor Levels
Description
Descriptive statistical analysis will be conducted. The estimates will be reported with 95% confidence intervals.
Time Frame
approximately 4 weeks of treatment
Title
Percent Change in Median PSA Values, pre- and postoperatively
Description
Pre- and postoperative PSA will be collected. Descriptive statistics will be conducted, comparing preoperative PSA level to postoperative level.
Time Frame
approximately 4 weeks of treatment
Title
Perioperative Analgesic Use, using morphine equivalents
Description
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.
Time Frame
Prostatectomy to discharge from hospital, no more than 30 days post prostatectomy
Title
Surgical Complications, defined as incidence of adverse events determined to be related to surgery graded by NCI CTCAE version 2.0
Description
Intraoperative and post surgical complications will be collected and reported.
Time Frame
Intraoperatively to 30 days postoperatively
Title
Incidence of Adverse Events, graded by NCI CTCAE version 2.0
Description
Descriptive statistical analysis will be conducted
Time Frame
From start of treatment to 30 days post prostatectomy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz M Beer, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207
Country
United States
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Pre-Prostatectomy Celecoxib or Placebo

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