PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy

NCT ID: NCT04843566

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 687 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2024-04-19

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.

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 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

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Transrectal

Patients will receive a transrectal MRI-guided prostate biopsy.

Group Type: ACTIVE_COMPARATOR

Transrectal MRI-guided prostate biopsy

Intervention Type: PROCEDURE

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

Antibiotic (prophylaxis)

Intervention Type: 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.

Transperineal

Patients will receive a transperineal MRI-guided prostate biopsy.

Group Type: ACTIVE_COMPARATOR

Transperineal MRI-guided prostate biopsy

Intervention Type: PROCEDURE

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

Interventions

Transperineal MRI-guided prostate biopsy

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

Intervention Type: PROCEDURE

Transrectal MRI-guided prostate biopsy

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

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim C Hu, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medicine, NewYork-Presbyterian

Locations

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

University of Michigan Medical School

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

Weill Cornell Medicine

New York, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40630527 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01CA241758

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-02-365-NIH

Identifier Type: OTHER

Identifier Source: secondary_id

20-04021956

Identifier Type: -

Identifier Source: org_study_id