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

NCT00596453 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-01-23

Study results available
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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.

Conditions

  • Prostate Infections

Interventions

DRUG

Ciprofloxacin hydrochloride

250 mg Ciprofloxacin hydrochloride twice a day for 14 days

DRUG

Placebo

Placebo twice a day for 14 days

Sponsors & Collaborators

Principal Investigators

  • Misop Han, M.D., M.S. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596453 on ClinicalTrials.gov