Six Weeks of Fluoroquinolone Antibiotic Therapy for Patients with Elevated Serum PSA is not Clinically Beneficial: A Randomized Controlled Clinical Trial.

OBJECTIVE - To evaluate asymptomatic men with elevated serum prostate specific antigen (PSA) to determine whether a six-week course of fluoroquinolone antibiotics lowers serum PSA and affects recommendations for prostate biopsy.

METHODS - A randomized, single-center prospective trial of 150 men with an initial elevated PSA was conducted. Patients were randomized to six weeks of ciprofloxacin or observation. Those patients with persistently elevated PSA were recommended to proceed with trans-rectal ultrasound guided (TRUS) 12-core biopsy. Those with reduced PSA were offered TRUS biopsy but could opt to continue serial DRE/PSA. Patients were followed an average of 4. 6 years to assess trends in PSA and biopsy results.

RESULTS - Of 136 men who completed the trial, 63 were in the treatment and 73 in the observation group. The average PSA change from baseline was borderline statistically significant with a change of -0. 68 ng/mL in the treatment arm and 0. 01 ng/mL in the observation arm (p = 0. 052). Of those who underwent biopsy, prostate cancer was diagnosed in the first biopsy in 24 (63%) of the treatment versus 27 (52%) of the observation group (p = 0. 60) over follow-up.

CONCLUSIONS - In a cohort of asymptomatic men with elevated PSA, there was only a borderline statistically significant change in serum PSA between patients randomized to a 6-week course of fluoroquinolones versus observation, and there was no difference in positive prostate biopsy results. Our clinical recommendation is one should not treat patients with elevated serum PSA with antibiotics in the absence of clinical symptoms of prostatitis.

Urology. 2016 Jan 20 [Epub ahead of print]

Alyssa Greiman, Jaimin Shah, Robin Bhavsar, Rabun Jones, Kent Armeson, Susan Caulder, Rabun Jones, Thomas E Keane, Harry S Clarke, Stephen J Savage

Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA. Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA. , Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA. , Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA. , Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA. , Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA. , Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA. , Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA. , Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA. , Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC, USA.

PubMed

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