Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596453
Recruitment Status : Terminated (Unable to recruit enough patients)
First Posted : January 17, 2008
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Ciprofloxacin hydrochloride has been approved by the Food and Drug Administration (FDA) for the treatment of mild to moderate infections, including prostate infections. It has been suggested that antibiotic treatment influences PSA levels due to the fact that an increase in PSA levels may be caused by inflammation or swelling of the prostate. Antibiotics are used to treat such inflammatory conditions. However, it has not been proven that antibiotics can be used to lower PSA. This research is being done to see if treatment with the antibiotic Ciprofloxacin hydrochloride affects the Prostate-Specific Antigen (PSA) blood test. This study may also help doctors in deciding which patients need a prostate biopsy.

Condition or disease Intervention/treatment Phase
Prostate Infections Drug: Ciprofloxacin hydrochloride Drug: Placebo Phase 4

Detailed Description:
This study is directed towards men who have been referred to the Urology clinic at the Johns Hopkins Outpatient Center in Baltimore, MD. If a patient fits the eligibility criteria and signs a consent form, the patient will have his blood drawn for the first PSA measurement. The patient must return to the Johns Hopkins Outpatient Center one week later for a second PSA measurement. The patient will be randomized to receive treatment with placebo or Ciprofloxacin hydrochloride for 14 days. The patient must return to the Johns Hopkins Outpatient Center at the end of the treatment cycle for the third PSA measurement. The patient will return one week later for his biopsy and fourth PSA measurement.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Impact of Antibiotic Treatment on PSA Variability
Study Start Date : January 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo twice a day for 14 days
Experimental: Ciprofloxacin hydrochloride Drug: Ciprofloxacin hydrochloride
250 mg Ciprofloxacin hydrochloride twice a day for 14 days

Primary Outcome Measures :
  1. PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy) [ Time Frame: 1 month post enrollment ]

    We took 4 Prostate Specific Antigen (PSA, ng/mL) measurements per participant. The first PSA test was performed at enrollment. The second PSA test was performed 7 days (+/-3 days) later. Then the participants took the Placebo or Cipro for 14 days. The participants returned for their 3rd PSA test upon completion of the Placebo or Cipro. The final PSA test was performed 7 days (+/-3 days) after the 3rd test.

    We planned to compare the differences between the first two PSA tests and the last two PSA tests in the Placebo vs Cipro groups.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be a patient of Johns Hopkins Urology Outpatient Clinic
  • Must have an elevated PSA (> 2.5 ng/mL) and be selected on the basis of a serum PSA evaluation for Transrectal Ultrasound (TRUS)/biopsy
  • Must be able to understand and willing to adhere to the study protocol
  • Must be willing to take the antibiotic or placebo for two weeks prior to the biopsy and agree to have the biopsy regardless of the change in PSA

Exclusion Criteria:

  • Abnormal digital rectal examination
  • Anyone currently being treated or who have been treated for any prostatic diseases (prostatitis, prostate Benign Prostatic Hyperplasia (BPH) surgery, prostate cancer) or urinary tract infection in the past
  • Anyone taking medications that are likely to alter serum PSA concentration (specifically, androgen steroid hormones, antiandrogens, finasteride, Leutinizing Hormone Releasing Hormone (LHRH) analogues)
  • Anyone unwilling to sign the informed consent or who are unlikely to adhere to the study protocol
  • Anyone with a known allergy to fluoroquinolone antibiotics
  • Anyone on blood thinning medication (Coumadin)
  • Anyone taking Tizanidine
  • Anyone with a history of seizures or cerebral arteriosclerosis
  • Anyone who has taken an antibiotic medication within the past two weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00596453

United States, Maryland
Johns Hopkins Hospital Outpatient Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Misop Han, M.D., M.S. Johns Hopkins University

Responsible Party: Johns Hopkins University Identifier: NCT00596453     History of Changes
Other Study ID Numbers: NA_00010549
First Posted: January 17, 2008    Key Record Dates
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017
Last Verified: November 2016

Keywords provided by Johns Hopkins University:
Prostate Specific Antigen (PSA)
Elevated Prostate Specific Antigen (PSA)

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors