PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2 (PREVENT2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infection
• Intervention / Treatment: Procedure: Transrectal MRI-guided prostate biopsy; Drug: Antibiotic (prophylaxis); Procedure: Transperineal MRI-guided prostate biopsy

Detailed Description

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

• Study Type: Interventional
• Enrollment (Estimated): 1302
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunmei McKernan; Phone Number: 212.746.4739; Email: chm4022@med.cornell.edu
• Study Contact Backup: Name: Dianis Rivera; Phone Number: 212.746.1496; Email: dir4010@med.cornell.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Not yet recruiting
      • University of Southern California
      • Contact: Andre Abreu; Email: Andre.Abreu@med.usc.edu
      • Principal Investigator: Andre Abreu
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • University of Connecticut
      • Contact: Katarzyna Nastri; Email: nastri@uchc.edu
      • Principal Investigator: Benjamin Ristau, MD
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • Georgetown University
      • Contact: Keith Kowalczyk, MD; Email: Keith.Kowalczyk@medstar.net
      • Principal Investigator: Keith Kowalczyk, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Principal Investigator: Edward M Schaeffer, MD PhD
      • Contact: Margarita "Sachi" Mana-ay, MSN, MPH; Phone Number: 312-695-8146; Email: Margarita.Mana-ay@nm.org
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Principal Investigator: Mohamad E Allaf, MD
      • Contact: Rana Harb, MS; Phone Number: 410-502-5500; Email: rharb1@jhmi.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Quoc-Dien Trinh; Email: QTRINH@BWH.HARVARD.EDU
      • Principal Investigator: Quoc-Dien Trinh
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Peter Chang; Email: pchang@bidmc.harvard.edu
      • Principal Investigator: Peter Chang
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Sharada Lanka, MS; Email: slanka@med.umich.edu
      • Contact: Jeffrey S Montgomery, MD; Phone Number: 734-647-8903; Email: montrose@med.umich.edu
  • New York
    • Brooklyn, New York, United States, 11217
      • Completed
      • NewYork-Presbyterian Brooklyn Methodist Hospital
    • Flushing, New York, United States, 11355
      • Recruiting
      • NewYork-Presbyterian Queens
      • Contact: Danielle Hayden; Phone Number: 646-962-9343; Email: daw7005@med.cornell.edu
      • Principal Investigator: David Green, MD
      • Principal Investigator: Gerald Wang, MD
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Marlena McGill; Phone Number: 646-227-2231; Email: mcgillm@mskcc.org
      • Principal Investigator: Behfar Ehdaie, MD MPH
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Not yet recruiting
      • University of North Carolina
      • Principal Investigator: Marc Bjurlin
      • Contact: Marc Bjurlin; Email: marc_bjurlin@med.unc.edu
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Rosemary Brewka, MS; Email: rosemary.brewka@uhhospitals.org
      • Principal Investigator: Jonathan Shoag, MD
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Recruiting
      • Einstein Healthcare Network
      • Contact: Serge Ginzburg, MD; Phone Number: 215-663-6067; Email: ginzburs@einstein.edu
      • Principal Investigator: Serge Ginzburg, MD
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Benjamin Schurhamer; Email: Benjamin.Schurhamer@Pennmedicine.upenn.edu
      • Principal Investigator: Benjamin Schurhamer
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
      • Principal Investigator: Andres Correa, MD
      • Contact: Victoria Sabella; Phone Number: 215-728-3122; Email: victoria.sabella@fccc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transrectal; Patients will receive a transrectal MRI-guided prostate biopsy.	Procedure: Transrectal MRI-guided prostate biopsy; Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.; Drug: Antibiotic (prophylaxis); For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.
Active Comparator: Transperineal; Patients will receive a transperineal MRI-guided prostate biopsy.	Procedure: Transperineal MRI-guided prostate biopsy; Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in infection adverse events, as measured on TRUS-BxQ	TRUS-BxQ is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaire consists of Yes/No questions about infection complications and duration of infection.	At initiation of biopsy, immediately following biopsy, 7 days post-biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient-reported pain and discomfort, as measured on a 0-10 Likert scale	Pain and discomfort will be scored on a 0-10 Likert scale. 0 indicates no pain/discomfort and high scores indicate greater pain/discomfort.	Immediately following biopsy, 7 days post-biopsy
Change in patient-reported anxiety, as measured on a 0-10 Likert scale	Anxiety will be scored on a 0-10 Likert scale. 0 indicates no anxiety and high scores indicate greater anxiety.	Immediately following biopsy, 7 days post-biopsy
Detection of clinically significant disease as measured by Gleason Grade Group ≥ 2	Gleason Grade Group is a prostate cancer grading system released by the International Society of Urological Pathology (ISUP). Grade Group 1 indicates Low/Very Low Risk, Grade Group 2 indicates Intermediate (Favorable) Risk, Grade Group 3 indicates Intermediate (Unfavorable) Risk, and Grade Groups 4 and 5 indicate High/Very High Risk. Prostate cancer grade will be categorized into insignificant (Gleason Grade Group 1) and clinically significant (Grade Group ≥ 2).	7 days post-biopsy
Change in adverse events, as measured on TRUS-BxQ	TRUS-BxQ is a validated biopsy questionnaire that measures adverse events that have occurred, such as hospital re-admissions, aborted procedures due to discomfort, hematuria, urinary retention, hematospermia, and/or hematochezia. Patient questionnaire consists of Yes/No questions about general complications and duration of adverse events.	At initiation of biopsy, immediately following biopsy, 7 days post-biopsy

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Jim C Hu, MD MPH, Weill Cornell Medicine, NewYork-Presbyterian

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: prostate cancer; prostate biopsy; transrectal; biopsy infection; fusion biopsy; MRI-targeted biopsy; transperineal
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 21-03023431; CER-2019C2-17372 (Other Identifier: Patient-Centered Outcomes Research Institute); 18-02-365-PCORI (Other Identifier: Biomedical Research Alliance of New York (BRANY))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No