Weill Medical College of Cornell University
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.
Infection
Transperineal MRI-guided prostate biopsy
Transrectal MRI-guided prostate biopsy
Antibiotic (prophylaxis)
NA
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 |
| Estimated Enrollment : | 1302 participants |
| Masking : | SINGLE |
| Masking Description : | Radiologists assessing MRI results are blinded to treatment assignment. Pathologists assessing biopsy results are blinded to treatment assignment. |
| Primary Purpose : | DIAGNOSTIC |
| Official Title : | Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications |
| Actual Study Start Date : | 2021-06-24 |
| Estimated Primary Completion Date : | 2025-06-01 |
| Estimated Study Completion Date : | 2025-06-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | MALE |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
NOT YET RECRUITING
University of Southern California
Los Angeles, California, United States, 90033
RECRUITING
University of Connecticut
Farmington, Connecticut, United States, 06030
RECRUITING
Georgetown University
Washington, District of Columbia, United States, 20007
RECRUITING
Northwestern University
Chicago, Illinois, United States, 60611
RECRUITING
Johns Hopkins University
Baltimore, Maryland, United States, 21287
RECRUITING
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
NOT YET RECRUITING
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
RECRUITING
University of Michigan
Ann Arbor, Road cancer, United States, 48109
COMPLETED
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11217
RECRUITING
NewYork-Presbyterian Queens
Flushing, New York, United States, 11355
RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
NOT YET RECRUITING
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
RECRUITING
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
RECRUITING
Einstein Healthcare Network
Elkins Park, Pennsylvania, United States, 19027
RECRUITING
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
RECRUITING
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111