title: Six Weeks of Fluoroquinolone Antibiotic Therapy for Patients With Elevated Serum Prostate-specific Antigen Is Not Clinically Beneficial: A Randomized Controlled Clinical Trial.
abstract: OBJECTIVE
  To evaluate asymptomatic men with elevated serum prostate-specific antigen (PSA) to determine whether a 6-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 6 weeks of ciprofloxacin or observation. Those patients with persistently elevated PSA were recommended to proceed with transrectal ultrasound-guided 12-core biopsy. Those with reduced PSA were offered transrectal ultrasound-guided biopsy but could opt to continue serial digital rectal examination/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 were 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  =  .052). Of those who underwent biopsy, prostate cancer was diagnosed in the first biopsy in 24 (63%) of the treatment vs 27 (52%) of the observation group (P  =  .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 vs 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.
authors.affiliation: Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC. Electronic address: greiman@musc.edu.
authors.forename: Alyssa
authors.initials: A
authors.lastname: Greiman
authors.affiliation: Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC.
authors.forename: Jaimin
authors.initials: J
authors.lastname: Shah
authors.affiliation: Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC.
authors.forename: Robin
authors.initials: R
authors.lastname: Bhavsar
authors.affiliation: Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC.
authors.forename: Kent
authors.initials: K
authors.lastname: Armeson
authors.affiliation: Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC.
authors.forename: Susan
authors.initials: S
authors.lastname: Caulder
authors.affiliation: Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC.
authors.forename: Rabun
authors.initials: R
authors.lastname: Jones
authors.affiliation: Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Keane
authors.affiliation: Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC.
authors.forename: Harry S
authors.initials: HS
authors.lastname: Clarke
authors.affiliation: Urology Section, Ralph H. Johnson Veterans Affairs Medical Center, Department of Urology, Medical University of South Carolina, Charleston, SC.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Savage
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D024841:Fluoroquinolones / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood* / Q000187:drug effects*; D011472:Prostatitis / Q000097:blood / Q000188:drug therapy / Q000382:microbiology
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D017430:Prostate-Specific Antigen