PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

Description

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.

Conditions

Infection

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Study Overview

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Study Details

Study overview

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.

Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications

PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

Condition
Infection
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Farmington

University of Connecticut, Farmington, Connecticut, United States, 06030

Washington

Georgetown University, Washington, District of Columbia, United States, 20007

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Brooklyn

NewYork-Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States, 11217

Flushing

NewYork-Presbyterian Queens, Flushing, New York, United States, 11355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Jim C Hu, MD MPH, PRINCIPAL_INVESTIGATOR, Weill Cornell Medicine, NewYork-Presbyterian

Study Record Dates

2025-06-01