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

NCT00596453 | Terminated Phase 4 Results

• 1 other identifier: NA_00010549
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy)

  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.

  1 month post enrollment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Ciprofloxacin hydrochloride

EXPERIMENTAL

Drug: Ciprofloxacin hydrochloride

Interventions

Ciprofloxacin hydrochloride DRUG

250 mg Ciprofloxacin hydrochloride twice a day for 14 days

Ciprofloxacin hydrochloride

Placebo DRUG

Placebo twice a day for 14 days

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital Outpatient Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Misop Han, M.D.
• Organization: Johns Hopkins Medical Institutions

mhan1@jhmi.edu

410-502-7454

Study Officials

• Misop Han, M.D., M.S.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 23, 2017
• Results First Posted: January 23, 2017

Record last verified: 2016-11

Locations

US (1)