Empiric antibiotics for an elevated PSA: A randomized, prospective multi-institutional trial.
32 Background: The impact of an empiric course of antibiotics for a newly elevated PSA in an asymptomatic male is poorly understood. Methods: Men of any age with a PSA > 2.5 ng/ml and normal digital rectal examination undergoing their first prostate biopsy were recruited from six medical centers. Patients with previous biopsy, prostate cancer, urinary tract infection (UTI) or prostatitis within the prior year, antibiotic use within one month, 5−alpha reductase inhibitor use, allergy to fluoroquinolones or clinical suspicion of UTI were excluded. Men were randomized to two weeks of ciprofloxacin 500 mg twice daily or no antibiotic. A PSA was obtained 21−45 days following randomization and immediately prior to prostate biopsy. All patients received institution−specific prophylactic peri−procedural antibiotics. Primary endpoint was change in PSA between baseline and on the day of biopsy. The trial was closed early following an interim analysis and decision rule for futility and early stopping. Results: Complete data was available on 77 men with a mean age of 60.6 (IQR: 53.8 – 66.7). In the control group (no antibiotic; n=39), mean baseline and pre−biopsy PSA were 6.5 and 6.9 ng/ml, respectively (p=0.8). In men receiving antibiotic (n=38), mean baseline and pre−biopsy (post−antibiotic) PSA were 7.6 and 8.5 ng/ml, respectively (p=0.7). Prostate cancer was detected in 36 (47%) men. Detection rates did not significantly differ between individuals with an increasing PSA or decreasing PSA between the two measurements. Conclusions: Empiric use of antibiotics for an elevated PSA in an asymptomatic patient is not of clinical benefit.