PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

Summary

Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer. This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy. The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.

Eligibility

Inclusion Criteria:

* Active surveillance cohort: History of Grade Group 1 prostate cancer, first diagnosed ≤24 months prior to date of planned confirmatory biopsy and diagnostic biopsy was preceded by a multiparametric MRI of the prostate
* Prior negative cohort: Clinical concern for the presence of prostate cancer as determined by the treating urologist and prior negative prostate biopsy performed ≤36 months prior to date of planned biopsy
* Willingness to sign informed consent and adhere to the study protocol

Exclusion Criteria:

* Acute prostatitis within the last 6 months
* Current non-urologic bacterial infection requiring active treatment with antibiotics
* Unfit to undergo prostate biopsy under local anesthesia
* Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
* Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)

Conditions2

Locations16 sites

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