Pre-Prostatectomy Celecoxib or Placebo

Prostate Cancer Clinical Trial

Official title:

Randomized Study of Pre-Prostatectomy Celecoxib or Placebo

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02840162
• Other study ID #: IRB00001004
• Secondary ID: HOR-01019-L
• Status: Terminated
• Phase: Phase 2
• First received: July 15, 2016
• Last updated: April 26, 2017
• Start date: May 2001
• Est. completion date: May 2011

Study information

• Verified date: April 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: May 2011
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Celecoxib
Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition
• Placebo

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 4 weeks of treatment
Secondary	Prostaglandin and Androgen Receptor Levels	Descriptive statistical analysis will be conducted. The estimates will be reported with 95% confidence intervals.	approximately 4 weeks of treatment
Secondary	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.	approximately 4 weeks of treatment
Secondary	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.	Prostatectomy to discharge from hospital, no more than 30 days post prostatectomy
Secondary	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.	Intraoperatively to 30 days postoperatively
Secondary	Incidence of Adverse Events, graded by NCI CTCAE version 2.0	Descriptive statistical analysis will be conducted	From start of treatment to 30 days post prostatectomy