PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy

NCT04843566 | Completed Results DMC

• 3 other identifiers: 20-040219561R01CA24175818-02-365-NIH
• Study Type: interventional
• Target: 687
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects That Experienced Infection, Urinary Retention or Bleeding Requiring Intervention Within 7 Days of Biopsy Based on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ)

  Outcome measure Description Now says: Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaires that reported infection complications and duration of symptoms, had their electronic medical records verified to confirm if an infection occurred or not.

  7 days post-biopsy

Secondary Outcomes (4)

• Percentage of Patient Reporting Biopsy Pain and Discomfort

  Immediately following biopsy, 7 days post-biopsy

• Change in Patient-reported Anxiety, as Measured on a 0-10 Likert Scale

  Immediately following biopsy

• Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2

  7 days post-biopsy

• Change in Adverse Events, as Measured on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ)

  7 days post-biopsy

Study Arms (2)

Transrectal

ACTIVE COMPARATOR

Patients will receive a transrectal MRI-guided prostate biopsy.

Procedure: Transrectal MRI-guided prostate biopsy; Drug: Antibiotic (prophylaxis)

Transperineal

ACTIVE COMPARATOR

Patients will receive a transperineal MRI-guided prostate biopsy.

Procedure: Transperineal MRI-guided prostate biopsy

Interventions

Transperineal MRI-guided prostate biopsy PROCEDURE

Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.

Transperineal

Transrectal MRI-guided prostate biopsy PROCEDURE

Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.

Transrectal

Antibiotic (prophylaxis) DRUG

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.

Transrectal

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male sex
• Age ≥18 years
• Men without previous prostate biopsy (first time prostate biopsy)
• Willingness to sign informed consent and adhere to the study protocol

You may not qualify if:

• Acute prostatitis within the last 6 months
• PSA \> 20 ng/mL in men who have previously undergone prostate biopsy
• 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
• Men who have previously undergone prostate biopsy in whom artifact would reduce quality of prostate MRI (extensive orthopedic pelvic metal)
• Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease) in men who have previously undergone prostate biopsy

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Michigan Medical School

Ann Arbor, Michigan, 48109-5624, United States

Location

NewYork Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11217, United States

Location

NewYork-Presbyterian Queens

Flushing, New York, 11355, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• Driscoll CB, Handa N, Huang MM, Murphy AB, Hu JC, Schaeffer EM. Evaluating PI-RADS lesions and clinically significant prostate cancer in Black and Asian men: a PREVENT randomized clinical trial secondary analysis. Prostate Cancer Prostatic Dis. 2025 Nov 26. doi: 10.1038/s41391-025-01057-5. Online ahead of print.

  PMID: 41298852 DERIVED

• Driscoll C, Handa N, Huang M, Murphy A, Hu J, Schaeffer E. Evaluating PI-RADS lesions and clinically significant prostate cancer in Black and Asian men: a PREVENT randomized clinical trial secondary analysis. Res Sq [Preprint]. 2025 Jul 4:rs.3.rs-6905600. doi: 10.21203/rs.3.rs-6905600/v1.

  PMID: 40630527 DERIVED

MeSH Terms

Conditions

Infections; Prostatic Neoplasms

Interventions

Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Premedication

Results Point of Contact

• Title: Jim Hu
• Organization: Weill Cornell Medicine

jch9011@med.cornell.edu

2127463418

Study Officials

• Jim C Hu, MD MPH

  Weill Cornell Medicine, NewYork-Presbyterian

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Radiologists assessing MRI results are blinded to treatment assignment. Pathologists assessing biopsy results are blinded to treatment assignment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Men enrolled in this prospective, randomized trial will be randomized in a 1:1 ratio to receive either transperineal MRI-targeted or transrectal MRI-targeted prostate biopsy.

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 13, 2021
• Study Start: March 22, 2021
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)