PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy (PREVENT)

• ClinicalTrials.gov Identifier: NCT04843566
• Recruitment Status: Active, not recruiting
• First Posted: April 13, 2021
• Last Update Posted: April 12, 2024
• Sponsor: Weill Medical College of Cornell University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Tracking Information

• First Submitted Date: April 10, 2021
• First Posted Date: April 13, 2021
• Last Update Posted Date: April 12, 2024
• Actual Study Start Date: March 22, 2021
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 13, 2021)

Change in infection adverse events, as measured on Transrectal Ultrasound Guided prostate Biopsy Questionnaire (TRUS-BxQ) [ Time Frame: At initiation of biopsy, immediately following biopsy, 7 days post-biopsy ]

Transrectal Ultrasound Guided prostate Biopsy Questionnaire (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.

Original Primary Outcome Measures (submitted: April 10, 2021)

Change in infection adverse events, as measured on TRUS-BxQ [ Time Frame: At initiation of biopsy, immediately following biopsy, 7 days post-biopsy ]

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.

Current Secondary Outcome Measures (submitted: May 13, 2021)

• Change in patient-reported pain and discomfort, as measured on a 0-10 Likert scale [ Time Frame: Immediately following biopsy, 7 days post-biopsy ]
  Pain and discomfort will be scored on a 0-10 Likert scale. 0 indicates no pain/discomfort and high scores indicate greater pain/discomfort.
• Change in patient-reported anxiety, as measured on a 0-10 Likert scale [ Time Frame: Immediately following biopsy, 7 days post-biopsy ]
  Anxiety will be scored on a 0-10 Likert scale. 0 indicates no anxiety and high scores indicate greater anxiety.
• Detection of clinically significant disease as measured by Gleason Grade Group ≥ 2 [ Time Frame: 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).
• Change in adverse events, as measured on Transrectal Ultrasound Guided prostate Biopsy Questionnaire (TRUS-BxQ) [ Time Frame: At initiation of biopsy, immediately following biopsy, 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.

Original Secondary Outcome Measures (submitted: April 10, 2021)

• Change in patient-reported pain and discomfort, as measured on a 0-10 Likert scale [ Time Frame: Immediately following biopsy, 7 days post-biopsy ]
  Pain and discomfort will be scored on a 0-10 Likert scale. 0 indicates no pain/discomfort and high scores indicate greater pain/discomfort.
• Change in patient-reported anxiety, as measured on a 0-10 Likert scale [ Time Frame: Immediately following biopsy, 7 days post-biopsy ]
  Anxiety will be scored on a 0-10 Likert scale. 0 indicates no anxiety and high scores indicate greater anxiety.
• Detection of clinically significant disease as measured by Gleason Grade Group ≥ 2 [ Time Frame: 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).
• Change in adverse events, as measured on TRUS-BxQ [ Time Frame: At initiation of biopsy, immediately following biopsy, 7 days post-biopsy ]
  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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy
• Official Title: Evaluation of Transperineal Biopsy Under Local Anesthesia, a Novel Approach to Decrease Post-Biopsy Infections and Improve Cancer Detection

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Single (Outcomes Assessor)
Masking Description:

Radiologists assessing MRI results are blinded to treatment assignment. Pathologists assessing biopsy results are blinded to treatment assignment.

Primary Purpose: Diagnostic

• Condition: Infection

Intervention

• Procedure: Transperineal MRI-guided prostate biopsy
  Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
• Procedure: Transrectal MRI-guided prostate biopsy
  Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.
• Drug: 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.

Study Arms

• Active Comparator: Transrectal
  Patients will receive a transrectal MRI-guided prostate biopsy.
  Interventions:

  • Procedure: Transrectal MRI-guided prostate biopsy
  • Drug: Antibiotic (prophylaxis)
• Active Comparator: Transperineal
  Patients will receive a transperineal MRI-guided prostate biopsy.
  Intervention: Procedure: Transperineal MRI-guided prostate biopsy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 4, 2024): 738
• Original Estimated Enrollment (submitted: April 10, 2021): 400
• Estimated Study Completion Date: June 2025
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04843566
• Other Study ID Numbers: 20-04021956; 1R01CA241758 ( U.S. NIH Grant/Contract ); 18-02-365-NIH ( Other Identifier: Biomedical Research Alliance of New York (BRANY) )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Weill Medical College of Cornell University
• Original Responsible Party: Same as current
• Current Study Sponsor: Weill Medical College of Cornell University
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jim C Hu, MD MPH; Weill Cornell Medicine, NewYork-Presbyterian

• PRS Account: Weill Medical College of Cornell University
• Verification Date: April 2024