Elevated Prostate Specific Antigen
Conditions
Keywords
Men with Elevated PSA
Brief summary
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.
Detailed description
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.
Interventions
DRUGCiprofloxacin
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men 18 yrs. or older * An elevated PSA (\>2.5 ng/ml) and normal digital rectal exam * Have elected to proceed with a diagnostic 12-core prostate biopsy
Exclusion criteria
* Previous prostate biopsy * History of prostate cancer * Urinary tract infections or prostatitis within one year of study entry * antibiotic use within one month prior to PSA level * pyuria or bacteruria on urinalysis * allergy to fluoroquinolones
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PSA Level From Baseline | At baseline and 21-45 days after randomization | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Infectious Complication Rate Following Prostate Biopsy | Within 24 hours of biopsy | To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observation Observation only for 2 weeks | 39 |
| Antibiotic Ciprofloxacin 500 mg twice daily for 2 weeks | 38 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Illness | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Observation | Antibiotic | Total |
|---|---|---|---|
| Age, Continuous | 61.7 years | 60.4 years | 60.6 years |
| PSA level | 6.5 ng/mL | 7.6 ng/mL | 7.0 ng/mL |
| Race/Ethnicity, Customized African-American | 12 participants | 10 participants | 22 participants |
| Race/Ethnicity, Customized Caucasian | 23 participants | 26 participants | 49 participants |
| Race/Ethnicity, Customized Other | 4 participants | 2 participants | 6 participants |
| Region of Enrollment United States | 39 participants | 38 participants | 77 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 39 Participants | 38 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 38 |
| serious Total, serious adverse events | 0 / 39 | 1 / 38 |
Outcome results
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).
Time frame: At baseline and 21-45 days after randomization
Population: Subjects with complete data are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observation | Change in PSA Level From Baseline | -0.08 log ng/mL | Standard Deviation 0.39 |
| Antibiotic | Change in PSA Level From Baseline | 0.005 log ng/mL | Standard Deviation 0.42 |
p-value: 0.33t-test, 2 sided
Secondary
Overall Infectious Complication Rate Following Prostate Biopsy
To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy
Time frame: Within 24 hours of biopsy
Population: Subjects with complete data are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observation | Overall Infectious Complication Rate Following Prostate Biopsy | 0 percentage of participants |
| Antibiotic | Overall Infectious Complication Rate Following Prostate Biopsy | 2.6 percentage of participants |