PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

NCT04815876 | Completed DMC FDA Device

• 3 other identifiers: 21-03023431CER-2019C2-1737218-02-365-PCORI
• Study Type: interventional
• Target: 1,030
• Locations: 1 country
• Sites: 16

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)

• 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 Outcomes (4)

• Change in patient-reported pain and discomfort, as measured on a 0-10 Likert scale

  Immediately following biopsy, 7 days post-biopsy

• Change in patient-reported anxiety, as measured on a 0-10 Likert scale

  Immediately following biopsy, 7 days post-biopsy

• Detection of clinically significant disease as measured by Gleason Grade Group ≥ 2

  7 days post-biopsy

• Change in adverse events, as measured on TRUS-BxQ

  At initiation of biopsy, immediately following biopsy, 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:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (16)

University of Southern California

Los Angeles, California, 90033, United States

Location

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

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, 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

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Einstein Healthcare Network

Elkins Park, Pennsylvania, 19027, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (2)

• Kaplan-Marans E, Zhang TR, Hu JC. Differing Recommendations on Prostate Biopsy Approach to Minimize Infections: An Examination of the European Association of Urology and American Urological Association Guidelines. Eur Urol. 2023 Nov;84(5):445-446. doi: 10.1016/j.eururo.2023.05.036. Epub 2023 Jun 7.

  PMID: 37296040 DERIVED

• Hu J, Zhu A, Vickers A, Allaf ME, Ehdaie B, Schaeffer A, Pavlovich C, Ross AE, Green DA, Wang G, Ginzburg S, Montgomery JS, George A, Graham JN, Ristau BT, Correa A, Shoag JE, Kowalczyk KJ, Zhang TR, Schaeffer EM. Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications. BMJ Open. 2023 May 19;13(5):e071191. doi: 10.1136/bmjopen-2022-071191.

  PMID: 37208135 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

Study Officials

• Jim C Hu, MD MPH

  Weill Cornell Medicine, NewYork-Presbyterian

  PRINCIPAL INVESTIGATOR

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: March 22, 2021
• First Posted: March 25, 2021
• Study Start: June 24, 2021
• Primary Completion: October 11, 2025
• Study Completion: October 11, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)