Clinical trial NCT04815876: PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
Official title: Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infection
Keywords: prostate cancer
prostate biopsy
biopsy infection
fusion biopsy
MRI-targeted biopsy
transperineal
transrectal
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2021-03-25
Enrollment: 1302
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in infection adverse events, as measured on TRUS-BxQ
timeFrame: At initiation of biopsy, immediately following biopsy, 7 days post-biopsy
Secondary outcomes:
measure: Change in patient-reported pain and discomfort, as measured on a 0-10 Likert scale
timeFrame: Immediately following biopsy, 7 days post-biopsy
measure: Change in patient-reported anxiety, as measured on a 0-10 Likert scale
timeFrame: Immediately following biopsy, 7 days post-biopsy
measure: Detection of clinically significant disease as measured by Gleason Grade Group ≥ 2
timeFrame: 7 days post-biopsy
measure: Change in adverse events, as measured on TRUS-BxQ
timeFrame: At initiation of biopsy, immediately following biopsy, 7 days post-biopsy
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Brooklyn
country: United States
facility: NewYork-Presbyterian Brooklyn Methodist Hospital
state: New York
city: Flushing
country: United States
facility: NewYork-Presbyterian Queens
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Elkins Park
country: United States
facility: Einstein Healthcare Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Weill Cornell Medicine, NewYork-Presbyterian
name: Jim C Hu, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: