drugset / Trial / NCT02840162

Pre-Prostatectomy Celecoxib or Placebo

NCT02840162

Phase 2 Terminated 34 enrolled OHSU Knight Cancer Institute Pfizer · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 400 mg Oral