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Pre-Prostatectomy Celecoxib or Placebo

NCT02840162 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-04-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Celecoxib

Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition

DRUG

Placebo

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Tomasz M Beer, MD · OHSU Knight Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2005-01-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02840162 on ClinicalTrials.gov