Prostate CancerPhase 2NCT02252978
Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy
A Phase 2 study testing ciprofloxacin, quality-of-life assessment and laboratory biomarker analysis in people with Prostate Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat infections caused by bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ciprofloxacin, quality-of-life assessment and laboratory biomarker analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abnormal serum PSA (total > 2.5 ng/ml or other clinically important biomarker parameters, including PSA velocity and density) associated with or without normal digital rectal examination
- Men who have elected to proceed with a diagnostic prostate biopsy
- Any prostate size
- Willingness and ability to give informed consent
Who cannot join
- History of prostate cancer
- Urine culture positive for significant urinary tract infection (UTI)
- A history of antibiotic use within one month prior to initial PSA level measurement
- Allergy to fluoroquinolones
- Currently taking imperative medications with significant drug-drug interaction with ciprofloxacin
- Compromised renal function with estimated glomerular filtration rate (GFR) of < 30 ml/min/1.73m^2
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Administration Medical Center.
Salisbury, North Carolina, 28144
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase II, Double-Blind, Placebo-Controlled Prospective Randomized Clinical Trial Evaluating the Role of an Empiric 2-Week Course of Ciprofloxacin on Rates of Detection of Cancer by Prostate Biopsy in Men With Abnormal Serum Prostate Specific Antigen Found at Screening (PREP Trial)
This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat infections caused by bacteria. Giving ciprofloxacin to patients undergoing a prostate biopsy may help to lower abnormal prostate-specific antigen (PSA) levels caused by bacterial infection of the prostate gland and may or may not affect the detection rate of prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the non-inferiority of the rate of detection of prostate cancer in men with decreased serum PSA values treated with placebo compared to ciprofloxacin prior to prostate biopsy.
SECONDARY OBJECTIVES:
- To compare the change in PSA from randomization to biopsy in men treated with ciprofloxacin versus those treated with placebo.
II. To compare the rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain) between men treated with ciprofloxacin versus those treated with placebo.
TERTIARY OBJECTIVES:
- To determine if benign prostatic hyperplasia (BPH) or erectile dysfunction are associated with abnormal PSA or prostatic inflammation reported in the biopsy specimen.
II. To determine the correlation between change in PSA from randomization to biopsy and urinalysis pre- and post-ciprofloxacin versus placebo.
III. To determine the correlation between change in PSA and prostate massage pre- and post-ciprofloxacin versus placebo.
IV. To determine the qualitative and quantitative difference in flora (ciprofloxacin resistant organisms) obtained from rectal swab pre- and post- two week course of ciprofloxacin vs. placebo.
- To correlate prostate symptom severity (International Prostate Symptom Score [IPSS]) with erectile function (International Index of Erectile Function [IIEF-5]) at baseline.
VI. To correlate urinary, prostate massage or rectal swab findings to pathology findings including cancer, inflammation, prostatic intra-epithelial neoplasia (PIN), atypical acinar proliferation (ASAP) or other findings at the end of the study.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ciprofloxacin orally (PO) twice daily (BID) for 2 weeks.
ARM II: Patients receive ciprofloxacin PO BID for 2 weeks.
- Conditions
- Prostate Cancer
- Being tested
- ciprofloxacin, placebo, quality-of-life assessment, laboratory biomarker analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofloxacinDrug
Also called Cipro, CPFX
Given PO
placeboOther
Also called PLCB
Given PO
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ciprofloxacin) | Experimental | Patients receive ciprofloxacin PO BID for 2 weeks. Receives: Drug: ciprofloxacin; Other: quality-of-life assessment; Other: laboratory biomarker analysis |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO BID for 2 weeks. Receives: Other: placebo; Other: quality-of-life assessment; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer detection rates
Will be compared between groups using a binomial test to compare rates in the two groups. Groups will also be compared using logistic regression models to adjust for any pre-treatment patient level characteristics.
Measured: Up to 8 weeks
Secondary outcomes (2)
Change in PSA
The data will be analyzed on a logarithmic scale to stabilize the variance. The change in log PSA from randomization to biopsy will be compared between the two groups using a two-sample t-test. In addition, the baseline log PSA levels will be compared between the two groups and if they are found to be imbalanced a 1-way analysis of covariance will be used to compare groups by including the baseline pre-randomization log-PSA value as the covariate in the model.
Measured: Up to 8 weeks
Rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain)
Will be compared between groups using Chi-square tests (or Fisher's Exact tests if the expected cell counts are below 5).
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startJul 2016
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: No funding support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- K. C. Balaji, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252978
- Sponsor's protocol ID
- IRB00028209
- Other IDs
- NCI-2014-01594, CCCWFU 99712, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 31 Jul 2014
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Placebo-Controlled Prospective Randomized Clinical Trial Evaluating the Role of an Empiric 2-Week Course of Ciprofloxacin on Rates of Detection of Cancer by Prostate Biopsy in Men With Abnormal Serum Prostate Specific Antigen Found at Screening (PREP Trial)
- ClinicalTrials.gov ID
- NCT02252978
- Acronym / sponsor ID
- IRB00028209
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat infections caused by bacteria. Giving ciprofloxacin to patients undergoing a prostate biopsy may help to lower abnormal prostate-specific antigen (PSA) levels caused by bacterial infection of the prostate gland and may or may not affect the detection rate of prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the non-inferiority of the rate of detection of prostate cancer in men with decreased serum PSA values treated with placebo compared to ciprofloxacin prior to prostate biopsy.
SECONDARY OBJECTIVES:
- To compare the change in PSA from randomization to biopsy in men treated with ciprofloxacin versus those treated with placebo.
II. To compare the rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain) between men treated with ciprofloxacin versus those treated with placebo.
TERTIARY OBJECTIVES:
- To determine if benign prostatic hyperplasia (BPH) or erectile dysfunction are associated with abnormal PSA or prostatic inflammation reported in the biopsy specimen.
II. To determine the correlation between change in PSA from randomization to biopsy and urinalysis pre- and post-ciprofloxacin versus placebo.
III. To determine the correlation between change in PSA and prostate massage pre- and post-ciprofloxacin versus placebo.
IV. To determine the qualitative and quantitative difference in flora (ciprofloxacin resistant organisms) obtained from rectal swab pre- and post- two week course of ciprofloxacin vs. placebo.
- To correlate prostate symptom severity (International Prostate Symptom Score [IPSS]) with erectile function (International Index of Erectile Function [IIEF-5]) at baseline.
VI. To correlate urinary, prostate massage or rectal swab findings to pathology findings including cancer, inflammation, prostatic intra-epithelial neoplasia (PIN), atypical acinar proliferation (ASAP) or other findings at the end of the study.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ciprofloxacin orally (PO) twice daily (BID) for 2 weeks.
ARM II: Patients receive ciprofloxacin PO BID for 2 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ciprofloxacin) | Experimental | Drug: ciprofloxacin, Other: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive ciprofloxacin PO BID for 2 weeks. |
| Arm II (placebo) | Placebo comparator | Other: placebo, Other: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive placebo PO BID for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Abnormal serum PSA (total > 2.5 ng/ml or other clinically important biomarker parameters, including PSA velocity and density) associated with or without normal digital rectal examination
- Men who have elected to proceed with a diagnostic prostate biopsy
- Any prostate size
- Willingness and ability to give informed consent
Key exclusion criteria (6 listed)
- History of prostate cancer
- Urine culture positive for significant urinary tract infection (UTI)
- A history of antibiotic use within one month prior to initial PSA level measurement
- Allergy to fluoroquinolones
- Currently taking imperative medications with significant drug-drug interaction with ciprofloxacin
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 |
|---|---|---|
| ciprofloxacinAlso: Cipro, CPFXGiven PO | Drug | Arm I (ciprofloxacin) |
| placeboAlso: PLCBGiven PO | Other | Arm II (placebo) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm I (ciprofloxacin), Arm II (placebo) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (ciprofloxacin), Arm II (placebo) |
Primary outcome
Prostate cancer detection rates
Time frame: Up to 8 weeks
Will be compared between groups using a binomial test to compare rates in the two groups. Groups will also be compared using logistic regression models to adjust for any pre-treatment patient level characteristics.
2 secondary outcomes
Change in PSA
Time frame: Up to 8 weeks
Rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain)
Time frame: Up to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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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.
K. C. Balaji principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ciprofloxacin, quality-of-life assessment and laboratory biomarker analysis in people with Prostate Cancer, run by Wake Forest University Health Sciences at 2 sites 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 6 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: withdrawn, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Prostate cancer detection rates (time frame: Up to 8 weeks). 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 5 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.