Prostate Infections
Conditions
Keywords
Prostate Specific Antigen (PSA), Elevated Prostate Specific Antigen (PSA)
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.
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.
Interventions
250 mg Ciprofloxacin hydrochloride twice a day for 14 days
DRUGPlacebo
Placebo twice a day for 14 days
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy) | 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. |
Countries
United States
Participant flow
Pre-assignment details
3 participants were enrolled but were removed prior to arm/group assignment. One participant was not eligible for the study and the other two participants changed their minds about being part of the research study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Placebo twice a day for 14 days | 13 |
| Ciprofloxacin Hydrochloride Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | Ciprofloxacin Hydrochloride | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 3 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 18 Participants |
| Age, Continuous | 62.73 years | 58.46 years | 60.75 years |
| Gender Female | 0 Participants | 0 Participants | 0 Participants |
| Gender Male | 15 Participants | 13 Participants | 28 Participants |
| Region of Enrollment United States | 15 participants | 13 participants | 28 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 13 | 1 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
Primary
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.
Time frame: 1 month post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy) | 1.23 ng/mL | Standard Deviation 0.6 |
| Ciprofloxacin Hydrochloride | PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy) | 0.52 ng/mL | Standard Deviation 0.59 |