Pre-Prostatectomy Celecoxib or Placebo

Phase 2

Terminated

• Conditions: Adenocarcinoma of the Prostate; Prostate Cancer
• Interventions: Drug: Celecoxib; Drug: Placebo

• Registration Number: NCT02840162
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2001-05
• Primary Completion: 2005-01
• Study Completion: 2011-05
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celecoxib	Celecoxib	Treated patients will receive 4 weeks of celecoxib at 400 mg twice daily by mouth
Placebo	Placebo	Control patients will receive a suitable placebo for 4 weeks, twice daily by mouth

Primary Outcome Measures

Name	Time	Method
Apoptosis Index, defined as the percent positive staining cells	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

Name	Time	Method
Incidence of Adverse Events, graded by NCI CTCAE version 2.0	From start of treatment to 30 days post prostatectomy	Descriptive statistical analysis will be conducted
Surgical Complications, defined as incidence of adverse events determined to be related to surgery graded by NCI CTCAE version 2.0	Intraoperatively to 30 days postoperatively	Intraoperative and post surgical complications will be collected and reported.
Prostaglandin and Androgen Receptor Levels	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	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	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.

Trial Locations

Locations (2)

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States