PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
NCT ID: NCT04815876
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1302 participants
INTERVENTIONAL
2021-06-24
2026-02-01
Brief Summary
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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.
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Detailed Description
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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 performed 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Transrectal
Patients will receive a transrectal MRI-guided prostate biopsy.
Transrectal MRI-guided prostate biopsy
Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.
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.
Transperineal
Patients will receive a transperineal MRI-guided prostate biopsy.
Transperineal MRI-guided prostate biopsy
Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Interventions
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Transperineal MRI-guided prostate biopsy
Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Transrectal MRI-guided prostate biopsy
Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
MALE
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Jim C Hu, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Weill Cornell Medicine, NewYork-Presbyterian
Locations
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University of Southern California
Los Angeles, California, United States
University of Connecticut
Farmington, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
NewYork-Presbyterian Queens
Flushing, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Einstein Healthcare Network
Elkins Park, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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CER-2019C2-17372
Identifier Type: OTHER
Identifier Source: secondary_id
18-02-365-PCORI
Identifier Type: OTHER
Identifier Source: secondary_id
21-03023431
Identifier Type: -
Identifier Source: org_study_id
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