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Combination of futility analysis and poor accrual
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The purpose of this study is to assess the impact of an empiric course of antibiotics for men with an elevated prostate-specific antigen (PSA) level.
Study Objectives:
Primary Objective: To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy
Secondary Objective: To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy
The impact of observation versus ciprofloxacin on PSA levels will be assessed by PSA change from baseline. The first PSA measurement will be at the study entry and randomization. The second PSA measurement will be immediately prior to prostate biopsy, which will occur 21-45 days following randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | No Intervention | Observation only for 2 weeks | |
| Antibiotic | Active Comparator | Ciprofloxacin 500 mg twice daily for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in PSA Level From Baseline | To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization. Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline). | At baseline and 21-45 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Infectious Complication Rate Following Prostate Biopsy | To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy | Within 24 hours of biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Eggener, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observation | Observation only for 2 weeks |
| FG001 | Antibiotic | Ciprofloxacin 500 mg twice daily for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects with complete data are included
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| ID | Title | Description |
|---|---|---|
| BG000 | Observation | Observation only for 2 weeks |
| BG001 | Antibiotic | Ciprofloxacin 500 mg twice daily for 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in PSA Level From Baseline | To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization. Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline). | Subjects with complete data are included | Posted | Mean | Standard Deviation | log ng/mL | At baseline and 21-45 days after randomization |
|
during the 2 weeks of study treatment
Subjects with complete data are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observation | Observation only for 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Non-systematic Assessment |
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Early termination due to poor accrual and interim futility analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Eggener | University of Chicago | (773) 702-5195 | seggener@surgery.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Illness |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| PSA level | Mean | Full Range | ng/mL |
|
|
|
|
| Secondary | Overall Infectious Complication Rate Following Prostate Biopsy | To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy | Subjects with complete data are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 24 hours of biopsy |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Antibiotic | Ciprofloxacin 500 mg twice daily for 2 weeks | 1 | 38 | 0 | 38 |
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |