Matthew J. Allaway, DO, discusses the need for a safe, precise and efficient option for performing prostate cancer biopsies via the transperineal approach and the limitations with the current standard of care, which is the transrectal approach, during No-Shave November awareness month.
Since the 1980s, the transrectal approach has been considered the gold standard for performing biopsies for prostate cancer despite the significant limitations and risks it presents to patients including the potential to develop serious infections and even sepsis. Clinicians had, unfortunately, been lacking the optimal tools and devices to adequately perform the transperineal approach, which offers a better option for patients compared to the transrectal approach. But new technologies have emerged in recent years that are designed to provide a safer and more precise option for performing prostate cancer biopsies via the transperineal method with the hope of transforming the current prostate cancer detection landscape and positioning clinicians to diagnose and treat cancer earlier.
A transrectal biopsy requires clinicians to insert a needle through a patient’s rectum to be able to access the prostate to take tissue samples. To get enough samples to confirm a prostate cancer diagnosis, clinicians need to perform about 12 needle sticks through the rectum. With each pass of the biopsy needle, patients are at risk of infection from fecal matter that can be introduced into the prostate.
Although antibiotics are generally prescribed to help reduce the risk of infection and associated complications, with the general increased use of antibiotics in healthcare in the last few decades, many bacteria (up to 25%) are now antibiotic resistant.1 As a result, many patients still end up developing infections and may even require hospitalization after transrectal biopsies. In some cases, patients may develop sepsis, which is fatal in 12%-25% of cases.2 Overall, the transrectal approach is associated with about a 5%-7% infection rate,3 which is significant considering the millions of prostate biopsies performed each year.
Other potential complications of a transrectal biopsy that patients may experience are rectal bleeding, urinary retention, pain, and erectile dysfunction.4 But more importantly, patients may also be at risk of their cancer being missed or mis-classified.
The transrectal approach is limiting in that it makes it difficult for clinicians to access certain areas of the prostate, especially the anterior portion where aggressive cancer is often found. Clinicians may need to perform multiple transrectal biopsies before a cancerous tumor in one of these hard-to-reach areas is identified, which exposes patients to all the same risks with this approach each time. In cases where cancer is mis-classified, a tumor may be characterized as slow growing when in fact it is aggressive and requires treatment, not active surveillance.
Despite the serious risks of infection and missing or misclassification of cancer, the transrectal approach has remained the standard of care for prostate cancer biopsies in the United States (US). It is difficult for many clinicians to accept the known complications and limitations with the transrectal approach, and until recently, the safer transperineal approach had not been a viable alternative.
The concept of passing a biopsy needle through the perineum instead of the rectum is not new, but until recently there was no effective technology available to perform a transperineal biopsy accurately and without presenting a different set of complications to patients. About 40 years ago, before there were advancements in ultrasound technology, clinicians would insert a specialized needle through the perineum to take tissue samples from the prostate, simply guiding the needle using their finger. But this method was not very accurate and resulted in significant patient morbidity rates.
In early 2000, a device called a grid-stepper was developed that significantly improved the accuracy of prostate cancer biopsies and eliminated the need to insert a needle through the rectum. But the device required clinicians to perform up to 60 needle sticks. The procedure also required use of general anesthesia and took up to one hour. While the transperineal approach was generally safer, it presented a number of challenges and several complications that made the risks outweigh the benefits, and so the transrectal approach remained the gold standard.
Over the last few years, a new device and surgical method has been developed that allows clinicians to perform a prostate cancer biopsy using the transperineal approach in a safe, precise and more efficient way. The new device has a unique design that enables thorough sampling of the entire prostate with only two needle sticks in the perineum, presenting little or no discomfort to patients. It also enables clinicians to perform a transperineal biopsy under local anesthesia in an office setting in a brief procedure (versus using general anesthesia in an operating room with the traditional transperineal and transrectal approaches).
Most importantly, by safely and accurately sampling the entire prostate, including the anterior portion, through the perineum instead of the rectum, this innovative technique results in about 30% better cancer detection rates5 and a nearly 0% infection rate.6 This new method also reduces the risk of complications such as bleeding and urinary retention.
There are multiple independent studies showing the significant benefits of this new technique and its ability to offer a better and safer transperineal prostate biopsy. This potentially life-saving method is quickly being adopted around the world – it is currently used in most of the top-rated urology centers in the US and in more than 13 other countries. Outside of the US, the transrectal approach to prostate cancer biopsy is being actively phased out. In just a couple of examples, the European Association of Urologists has changed their guidelines, recommending that the transperineal biopsy be offered unless it cannot be performed due to special circumstances,7 and in Australia reimbursement for prostate cancer biopsies has been reduced for clinicians who use the transrectal approach.
There has been incredible progress in shifting the gold standard from the transrectal to the transperineal approach in recent years, but we still have a long way to go in terms of generating broader awareness as most biopsies are still performed using the transrectal pathway. It is important that clinicians find both the time and the platforms to share insights and learnings with one another and spotlight this new biopsy approach that offers advantages for both them and their patients. It is also essential that clinicians share all of the biopsy options available with their patients and families so that they can make the best decisions for their health.
1. Liss M, Chang A Santos R, et al. Prevalence and significance of flouroquinolone resistance of Escherichia coli in patients undergoing transrectal ultrasound guided prostate needle biopsy. J Urol. 2021; 84: 395-99. doi: 10.1016/j.juro.2010.11.088
2. Fleischmann C, Scherag A, Adhikari N, et al. Assessment of global incidence and mortality of hospital-treated sepsis. Current estimates and limitations. Am J Respir Crit Care Med. 2016; 193(3): 259-72. doi: 10.1164/rccm.201504-0781OC
3. The Prevention and Treatment of the More Common Complications Related to Prostate Biopsy Update. American Urological Association. https://www.auanet.org/guidelines/guidelines/prostate-needle-biopsy-complications. Accessed November 8, 2021
4. Weiner A, Manjunath A, Kirsh GM, et al. The cost of prostate biopsies and their complications: a summary of data of all Medicare fee for service over 2 years. Urol Pract. 2020; 7(2): 145-51. doi: 10.1097/UPJ.0000000000000072
5. Ristau B, Allaway M, Cendo D, et al. Free-hand transperineal prostate biopsy provides acceptable cancer detection and a minimum risk of infection: evolving experience with a 10-sector template. Urol Oncol. 2018; 36; 528. doi: 10.1016/j.urolonc.2018.09.013
6. Lopez J, et al. Local anesthesia transperineal (LATP) prostate biopsy using a probe-mounted transperineal access system: a multicentre prospective outcome analysis. BJU Int. 2021; 128(3); 311-18. doi: 10.1111/bju.15337
7. Prostate Cancer: Guidelines. European Association of Urology. https://uroweb.org/guideline/prostate-cancer/. Accessed November 8, 2021.