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