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Completed NCT04815876

PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

Conditions: Infection

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1040
Sponsor: Weill Medical College of Cornell University

Location: University of Southern California Los Angeles California

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 Criteria

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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04815876). StuddyBuddy aggregates publicly available trial information.