Rapid CommunicationsSingle-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy☆
Section snippets
Patient population and study design
This was a prospective, randomized, double-blind, placebo-controlled trial conducted at five centers from January 1992 to March 1993. Male patients at least 18 years of age who required transrectal needle biopsy of the prostate were eligible for enrollment. If the patient met inclusion criteria, written informed consent was obtained and the patient underwent a complete history and physical examination before study enrollment. Blood specimens were obtained before biopsy for routine hematologic,
Results
A total of 557 adult men were enrolled in this multicenter trial, which included five study sites. At a sixth site, 20 patients were excluded from the efficacy and safety analyses because clinical and laboratory data could not be verified. Five hundred thirty-seven patients (269 in the ciprofloxacin group and 268 in the placebo group), with a mean age of 69.1 years (range 41 to 88), comprised the safety (intent-to-treat) population. Four hundred fifty-seven patients (85%; 227 ciprofloxacin and
Comment
With the advent of prostate-specific antigen and increased patient awareness of prostate cancer, there has been an increase in the number of needle biopsies performed in the United States. The development of automated biopsy devices and the ability to directly visualize the prostate using TRUSP has made the transrectal route the preferred method for performing needle biopsy of the prostate. Although antimicrobial prophylaxis may be routinely used by urologists for this procedure, to date there
Acknowledgements
To Adrienne L. Block, Ph.D. and Teresa Tartaglione, Pharm.D. for editorial and scientific contributions; Daniel Haverstock, M.S. for statistical review; and Amy Plofker for copyediting and preparation of the manuscript.
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This work was supported by a research grant from Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut.