Pre-Prostatectomy Celecoxib or Placebo
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Adenocarcinoma of the Prostate, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT02840162
- Run by
- OHSU Knight Cancer Institute
- People needed
- 34
- Starts
- 2001-05-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2017-04-28
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Portland VA Medical Center — Portland, Oregon, United States
- OHSU Knight Cancer Institute — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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