Six Weeks of Fluoroquinolone Antibiotic Therapy for Patients with Elevated Serum PSA is not Clinically Beneficial: A Randomized Controlled Clinical Trial (#URL-D-15-01365R2)
Abstract
Prostate specific antigen (PSA) levels are often evaluated in an attempt to detect early prostate cancer, however false positive PSA tests are common.1 A strategy to limit false positives, surrounding concerns that prostatitis may increase PSA, has been to defer biopsy decisions until after a course of antibiotics and repeat PSA measurement. This strategy has been evaluated in prior studies, including several small randomized trials, with differing conclusions regarding its benefit.2–4
The authors report a prospective, randomized trial investigating the impact of six weeks of fluoroquinolone antibiotics on PSA levels in asymptomatic men with an elevated PSA. This single-institution study randomized 150 of 1,151 eligible patients with a PSA between 4.0 and 20.0 ng/mL to 6 weeks of fluoroquinolone therapy (ciprofloxacin, but due to formulary changes a proportion received levofloxacin) or 6 weeks of observation. The primary endpoint was change in PSA 8 weeks after randomization. Rate of cancer diagnosis was a secondary outcome for patients who received a biopsy. A near significant difference in the change in PSA across groups was reported (−0.68 vs. 0.01 ng/mL for treatment and observation groups, respectively, p=0.052). 62% of treatment patients and 72% of observation patients underwent biopsy with no difference in cancer detection rate (63% vs. 52%, respectively, p=0.60). The authors conclude that asymptomatic patients with elevated PSA should not receive antibiotics prior to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,151 participants or records.
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