Prostate InfectionsPhase 4NCT00596453
Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability
A Phase 4 study testing Ciprofloxacin hydrochloride in people with Prostate Infections, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Infections
- What is being tested?
- Ciprofloxacin hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Anyone taking Tizanidine
- Anyone with a history of seizures or cerebral arteriosclerosis
- Anyone who has taken an antibiotic medication within the past two weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hospital Outpatient Center
Baltimore, Maryland, 21287
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Infections
- Being tested
- Ciprofloxacin hydrochloride, Placebo
- Keywords
- Prostate Specific Antigen (PSA), Elevated Prostate Specific Antigen (PSA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin hydrochlorideDrug
250 mg Ciprofloxacin hydrochloride twice a day for 14 days
PlaceboDrug
Placebo twice a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Ciprofloxacin hydrochloride | Experimental | Not described Receives: Drug: Ciprofloxacin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Unable to recruit enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misop Han, M.D., M.S., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596453
- Sponsor's protocol ID
- NA_00010549
- Status last verified
- Nov 2016
- First submitted
- 8 Jan 2008
- Last updated
- 23 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antibiotic Treatment on PSA Variability
- ClinicalTrials.gov ID
- NCT00596453
- Acronym / sponsor ID
- NA_00010549
- Conditions
- Prostate Infections
- Keywords
- Prostate Specific Antigen (PSA), Elevated Prostate Specific Antigen (PSA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit enough patients
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Posted 23 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Ciprofloxacin hydrochloride | Experimental | Drug: Ciprofloxacin hydrochloride |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacin hydrochloride250 mg Ciprofloxacin hydrochloride twice a day for 14 days | Drug | Ciprofloxacin hydrochloride |
| PlaceboPlacebo twice a day for 14 days | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misop Han, M.D., M.S. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofloxacin hydrochloride in people with Prostate Infections, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy) (time frame: 1 month post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.