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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

January 8, 2008
January 17, 2008
August 16, 2016
January 23, 2017
January 23, 2017
January 2008
June 2011   (Final data collection date for primary outcome measure)
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.

PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy) [ Time Frame: end of study ]
Complete list of historical versions of study NCT00596453 on ClinicalTrials.gov Archive Site
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Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability
Impact of Antibiotic Treatment on PSA Variability
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Prostate Infections
  • Drug: Ciprofloxacin hydrochloride
    250 mg Ciprofloxacin hydrochloride twice a day for 14 days
  • Drug: Placebo
    Placebo twice a day for 14 days
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Ciprofloxacin hydrochloride
    Intervention: Drug: Ciprofloxacin hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
40 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00596453
NA_00010549
No
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Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Misop Han, M.D., M.S. Johns Hopkins University
Johns Hopkins University
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP