PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy

Not Applicable

Completed

Conditions: Infection

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

Registration Number: NCT04843566

Lead Sponsor: Weill Medical College of Cornell University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 687

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transrectal	Transrectal MRI-guided prostate biopsy	Patients will receive a transrectal MRI-guided prostate biopsy.
Transrectal	Antibiotic (prophylaxis)	Patients will receive a transrectal MRI-guided prostate biopsy.
Transperineal	Transperineal MRI-guided prostate biopsy	Patients will receive a transperineal MRI-guided prostate biopsy.

Primary Outcome Measures

Name	Time	Method
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)	7 days post-biopsy	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patient Reporting Biopsy Pain and Discomfort	Immediately following biopsy, 7 days post-biopsy	Patient reported pain via a yes/no questionnaire
Change in Patient-reported Anxiety, as Measured on a 0-10 Likert Scale	Immediately following biopsy	Anxiety will be scored on a 0-10 Likert scale. 0 indicates no anxiety and high scores indicate greater anxiety.
Change in Adverse Events, as Measured on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ)	7 days post-biopsy	Transrectal Ultrasound Guided prostate Biopsy Questionnaire (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.
Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2	7 days post-biopsy	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).

Trial Locations

Locations (10): University of Connecticut
🇺🇸
Farmington, Connecticut, United States
University of Michigan Medical School
🇺🇸
Ann Arbor, Michigan, United States
Georgetown University
🇺🇸
Washington, District of Columbia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
NewYork-Presbyterian Queens
🇺🇸
Flushing, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
NewYork Presbyterian Brooklyn Methodist Hospital
🇺🇸
Brooklyn, New York, United States
Weill Cornell Medicine
🇺🇸
New York, New York, United States