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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Prostate Infections

In brief

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.

Key facts

Study ID

NCT00596453

Run by

Johns Hopkins University

People needed

31

Starts

2008-01-01

Expected to finish

2011-06-01

Last updated by the study team

2017-01-23

Who can join

Age: 40 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital Outpatient Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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