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

Sponsor:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00596453

Purpose

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	Intervention	Phase
Prostate Infections	Drug: Ciprofloxacin hydrochloride Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Impact of Antibiotic Treatment on PSA Variability

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

PSA levels (change in PSA levels with and without antibiotics therapy) [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment:	31
Study Start Date:	January 2008
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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 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 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, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596453

Locations

United States, Maryland
Johns Hopkins Hospital Outpatient Center
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Misop Han, M.D., M.S.

Johns Hopkins Medical Institutions

More Information

No publications provided

Responsible Party:	Misop, Han, M.D. / Assistant Professor, Johns Hopkins Medical Institutions
ClinicalTrials.gov Identifier:	NCT00596453 History of Changes
Other Study ID Numbers:	NA_00010549
Study First Received:	January 8, 2008
Last Updated:	June 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Prostate Specific Antigen (PSA)
Elevated Prostate Specific Antigen (PSA)

Additional relevant MeSH terms:

Anti-Bacterial Agents
Ciprofloxacin
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012