Implementation of transperineal biopsy clinic

March 03, 2023

Prostate biopsy plays a critical role in the diagnostic pathway for prostate cancer. For many years, the transrectal biopsy was the standard of care. During this procedure, needles are passed through the rectal wall to obtain tissue samples from the prostate. While effective at finding prostate cancer, the procedure carries a risk of infection — fever in 6%, sepsis in 2% — rectal bleeding and undersampling of the anterior prostate.

In recent years, the transperineal biopsy has gained popularity among urologists worldwide. The transperineal approach involves passing needles through the perineum versus the rectum. Data suggest that this procedure carries a significantly lower risk of infection and improved targeting in areas of the prostate previously considered more challenging.

Under the leadership of Derek J. Lomas, M.D., Pharm.D., Urology, at Mayo Clinic in Rochester, Minnesota, the department transition to transperineal prostate biopsy in 2019, which resulted in an increase in demand for the procedure. A departmental goal was set to offer this procedure in the clinic with local anesthesia, known as local anesthetic transperineal (LATP) prostate biopsy. However, it became apparent that the demand for transperineal biopsy outpaced physician availability.

Urology has seen success with implementation of advanced practice providers (APPs) performing clinic-based procedures including cystoscopy, percutaneous tibial nerve stimulation (PTNS) and a myriad of men's health procedures. Given the proven track record of APPs performing procedures, as well as documented success in the United Kingdom with nurse practitioners performing LATP biopsies, an APP-led transperineal biopsy clinic was developed at Mayo Clinic.

Everyone involved, including consultants, APPs, nurses, technicians and administrators, supported the practice's vision, which ultimately led to its success. The department worked hard to develop a training program and a practice model to safely implement the APP-led practice.

Training involved a didactic phase and an observation phase followed by a phase in which biopsies were performed under direct supervision of a trained staff member. Following successful completion of training, the APP-led transperineal biopsy clinic opened in late 2020.

Safety and quality were of utmost importance with implementation of this practice. Following completion of the first 100 biopsies, an analysis of initial data was conducted, focusing on cancer detection rates and adverse events — hematuria requiring intervention, urinary retention, postprocedural sepsis and vasovagal episodes — during or following biopsy. Sixty-one of the biopsies were performed using MRI fusion and 39 were performed in a systematic fashion. These data included patients who were presenting for initial biopsy, repeat biopsy or active surveillance biopsy.

Of the first 100 biopsies, 78 demonstrated prostate cancer. Of those positive biopsies, 75.6% (59 of 78) demonstrated clinically significant disease defined as Gleason 7 or greater.

After the biopsies, no episodes of urinary retention, hematuria requiring intervention or post-procedural sepsis were documented. Two patients experienced vasovagal episodes but were successfully discharged after an extended recovery time.

The implementation of this APP-led practice has resulted in more-timely patient access to prostate biopsy without sacrificing safety or quality. Additionally, it has allowed surgeons to focus on aspects of surgical and clinical care beyond the APP scope of practice. Finally, APPs performing these biopsies have all reported an increase in job satisfaction due to increased variety in their practice.

Today, a team of three APPs have performed over 1,000 LATP biopsies, which has significantly increased access for patients who want to proceed with the procedure. Access has increased by over 100% for the LATP biopsy practice. With preliminary data showing that these biopsies can be performed safely and effectively by a properly trained APP, finalized data are promising and will be published later in 2023.

In the future, APPs will play a significant role in changing the landscape of prostate cancer screening to help make the transperineal prostate biopsy standard of care.

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