Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy

Study Overview
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Brief Summary
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The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or standard of care (control) prostate biopsy. The subjects will have a rectal culture swab performed prior to the prostate biopsy. One rectal culture swab will be used for rapid multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The subjects randomized to the intervention group will have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. The subjects randomized to the control group will not have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days after the prostate biopsy, the research staff will conduct a chart review and/or telephone call to ask about any prostate biopsy infections and complications.

Official Title
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Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy

Conditions
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Antibiotic Therapy, Prostate Biopsy

Intervention / Treatment
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* Other: rPCR results
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be able to give informed consent Be age 50 or older Recommended to undergo a prostate biopsy No allergy or side effect to fluoroquinolone antibiotics No history of prostate biopsy infection No hepatic or renal insufficiency in which fluoroquinolone antibiotics are contraindicated. Exclusion Criteria: Unable to give informed consent Age < 50 Not recommended to have prostate biopsy Allergic to or have side effects to fluoroquinolone antibiotics History of prostate biopsy infection Hepatic or renal insufficiency in which fluoroquinolones antibiotics are contraindicated.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Men scheduled for prostate biopsy randomized to Control<br> | Other: Control group<br>* Control group: rPCR results will not be shared with the clinical provider at time of standard of care prostate biopsy. Standard of care antibiotic selection will be up to the discretion of the clinical provider.<br>|
| Experimental: Men scheduled for a prostate biopsy randomized to Intervention<br> | Other: rPCR results<br>* Interventional group: rPCR results will be shared with the clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care prostate biopsy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy. | Reduction in dual antibiotic prophylaxis in the intervention vs.usual care groups. | Day of prostate biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if rapid qPCR test results in longer patient wait times. | Difference in the amount of time the PCR technique takes compared to the fastest workflow (physician chooses no additional antibiotics). | Day of prostate biopsy | 
| Determine if rPCR results and standard rectal culture results are the same. | Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar. | 1 week |