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Celecoxib in Men Pre-Prostatectomy for Localized Prostate Cancer
NCT00022399Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2002
- Primary completion
- Jan 2005
- Countries
- 1
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center
- Modality
- Small Molecules
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, randomised, double-blind trial of celecoxib oral solution in prostate cancer (PCa) (2 arms), sponsored by Sidney Kimmel Comprehensive Cancer Center. Primary endpoint: Biomarker modulation (prostaglandin levels). Started Apr 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Celecoxib
Oral neoadjuvant celecoxib 400mg twice daily
Placebo
Oral neoadjuvant placebo twice daily
03
Who it enrols
Men aged 18+ with histologically confirmed localized adenocarcinoma of the prostate (Gleason >=7, PSA >=15, or T2b/c) planned for radical prostatectomy. Excludes prior PCa therapy, active infection, HIV, and recent use of NSAIDs/aspirin.
04
Endpoints
Primary
Biomarker modulation (prostaglandin levels)
Secondary
Angiogenic factors within the prostate
Pharmacokinetic and pharmacodynamic effects
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