Untargeted Prostate Biopsies: Where Do They Fall Short?

Prostate cancer is the leading cancer affecting men, comprising nearly 15% of all new cancer cases each year.1 However, despite the high prevalence rate, the status quo in prostate biopsies often fails to meet diagnostic needs, resulting in false results, repeat biopsies, and, in some cases, delayed detection and intervention. The primary culprit driving suboptimal cancer detection is often the imaging protocol accompanying the biopsy — namely, untargeted or “blind” biopsies guided only by ultrasound (US) imaging.

Identifying the Critical Limitations of Untargeted Biopsies

Blind, US-guided workflows and current biopsy collection techniques have significant impact on accurate detection and staging of prostate cancer, including:

• Low-quality samples that exclude cancerous tissue. Instead of leveraging an MRI-guided, targeted focus to biopsy specific sites suspected to have cancerous tissue, a blind 12-core needle biopsy collects samples from various regions of the prostate. As a result, untargeted biopsies have been shown to misdiagnose 46% of men with high-grade disease (Gleason score of 7 or higher) and detect more cases of insignificant disease.2
  

• Tissue damage necessitating a repeat biopsy. After the sample is collected, standard biopsy transfer, transport and processing workflows may cause irreparable damage to core integrity. This can lead to core fragmentation and tangling, potentially losing up to 40% of tissue, including fragile cancerous segments, which jeopardizes biopsy results and requires patients to undergo a repeat biopsy procedure.3

The Growing Role of Fusion in Prostate Cancer Diagnostics

Despite the clear disadvantages of blind biopsies, many urologists continue to perform US-guided biopsies on biopsy-naïve patients, only leveraging advanced magnetic resonance imaging (MRI) technology for repeat procedures. To help close precision gaps and accelerate cancer detection, the AUA now recommends MRI-US fusion biopsies for all patients at risk of developing prostate cancer, as fusion biopsy is the only technique proven to deliver a comprehensive, accurate picture of prostate anatomy. MRI-US fusion biopsies empower earlier detection of high-grade disease by providing localized targets for the biopsy needle, achieving 93% sensitivity in detecting high grade cancer with a Gleason score above 4 + 3 — compared to a 48% sensitivity from standard US-guided biopsies.4

How New Technology Is Elevating the Standard in Fusion Precision

However, with many fusion technologies, patient movement during biopsy is a critical weakness, necessitating constant stopping and starting to realign the MRI image with the ultrasound. If this is not done accurately, biopsy targets can be compromised. With the Navigo 4D Fusion Navigation System, urologists can adapt to patient motion in real-time with automatic movement compensation, bypassing the need for manual recalibration or workflow disruptions. Navigo is the only fusion navigation system equipped with this technology, creating new fusion efficiencies while driving a high level of precision with two to three times higher sensitivity to prostate cancer.5

To ensure precision from start to finish, SmartBx seamlessly integrates into the Navigo workflow, transferring and processing samples without damaging the biopsied cores. The clinician can rapidly transition the specimen from needle to cartridge without changing the core location or orientation, ensuring cancerous tissue remains intact for precise localization on each core on the pathology slide. By preserving prostate tissue integrity, the SmartBx biopsy management system has been proven to independently increase cancer detection rates by 25%.6

Together, Navigo and SmartBx are making high-quality fusion biopsies possible in the office setting. In addition to creating streamlined and predictable workflows, urology practices can also improve their financial outcomes, leveraging our unique pay-per-procedure model to minimize upfront costs and maximize reimbursements.

Interested in learning more? Download the white paper to learn how bringing fusion in-house can enhance clinical and business outcomes for your practice. If you’re ready to see Navigo and SmartBx in action, book a demo to learn more about how this technology is redefining the status quo in prostate cancer diagnostics.

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Sources

1. Cancer Stat Facts: Prostate Cancer. (2022). National Cancer Institute: Surveillance, Epidemiology, and End Results Program. https://seer.cancer.gov/statfacts/html/prost.html

2. Eklund M, Jäderling F, Discacciati A, et al. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021;385(10):908-920.

3. 2015 American Urology Association Conference Presentation by Johns Hopkins.

4. Ahmed HU, El-Shater Bosaily A, Brown LC, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017;389(10071):815-822.

5. Marks L, Young S, Natarajan S. MRI-ultrasound fusion for guidance of targeted prostate biopsy. Curr Opin Urol. 2013;23(1):43-50.

6. Arnon Lavi, Boris Yudkevick, et. al. Implications of a Novel Biopsy Downloading System on Prostate Cancer Detection Rate, Surveillance and Focal Therapy − A Prospective Study.2021 Elsevier Inc.