RECRUITING

PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-06-24
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04815876

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * Willingness to sign informed consent and adhere to the study protocol
  1. * Acute prostatitis within the last 6 months
  2. * Current non-urologic bacterial infection requiring active treatment with antibiotics
  3. * Unfit to undergo prostate biopsy under local anesthesia
  4. * Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
  5. * Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)

Contacts and Locations

Study Contact

Dianis Rivera, BS
CONTACT
212.746.1496
dir4010@med.cornell.edu
Xiaohong Jing, PhD
CONTACT
212-746-4739
xij2004@med.cornell.edu

Principal Investigator

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

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States
University of Connecticut
Farmington, Connecticut, 06030
United States
Georgetown University
Washington, District of Columbia, 20007
United States
Northwestern University
Chicago, Illinois, 60611
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11217
United States
NewYork-Presbyterian Queens
Flushing, New York, 11355
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Einstein Healthcare Network
Elkins Park, Pennsylvania, 19027
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-24
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2021-06-24
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • prostate cancer
  • prostate biopsy
  • biopsy infection
  • fusion biopsy
  • MRI-targeted biopsy
  • transperineal
  • transrectal

Additional Relevant MeSH Terms

  • Infection