Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer

Phase 2 Completed 73 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins National Cancer Institute (NCI) · collab

RandomizedSequentialDouble-blindPrevention

Summary

RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer. PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer.

Timeline

Start: 2002-04-25
Primary completion: 2005-01-31
Completion: 2005-01-31

Outcome

Missed primary endpoint

paper There were no treatment differences in any of the primary or secondary outcomes. PMID 19720908 ↗

Publications

Results Antonarakis ES, Heath EI, Walczak JR, Nelson WG, Fedor H, De Marzo AM, Zahurak ML, Piantadosi S, Dannenberg AJ, Gurganus RT, Baker SD, Parnes HL, DeWeese TL, Partin AW, Carducci MA. Phase II, randomized, placebo-controlled trial of neoadjuvant celecoxib in men with clinically localized prostate cancer: evaluation of drug-specific biomarkers. J Clin Oncol. 2009 Oct 20;27(30):4986-93. doi: 10.1200/JCO.2009.21.9410. Epub 2009 Aug 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	400 mg	Oral