What is Fusion Biopsy?
Fusion biopsy is an advanced biopsy technique that uses real-time MRI-TRUS (transrectal ultrasound) fusion technology to target and sample areas of the prostate that appear suspicious on multiparametric MRI (mpMRI). Traditionally, prostate biopsies were performed using standard TRUS alone. TRUS biopsies sample only a small fraction of the total prostate volume, often missing cancers that could be detected using additional targeting information from mpMRI. Fusion biopsy aims to overcome the limitations of standard biopsy by fusing pre-biopsy mpMRI findings with real-time TRUS imaging to target biopsies directly to areas that appear suspicious on the mpMRI. This allows providers to sample higher-risk regions of the prostate that may contain cancer with greater accuracy and detection rates compared to standard biopsy alone.
How Does Fusion Biopsy Work?
Fusion Biopsy requires both a pre-biopsy mpMRI scan and the use of specialized software and hardware to fuse the mpMRI with real-time TRUS imaging during the biopsy procedure itself. The pre-biopsy mpMRI scan uses various MRI sequences like T2-weighted, diffusion-weighted, and dynamic contrast-enhanced imaging to characterize areas of the prostate that appear abnormal. Regions that light up as suspicious on two or more MRI sequences are deemed clinically significant. During the actual fusion biopsy procedure, the patient first undergoes real-time TRUS imaging of the prostate. Then using proprietary software and an electromagnetic tracking system, the pre-biopsy mpMRI images are co-registered or fused onto the real-time TRUS images. This allows the provider to visualize both the anatomy on TRUS and any suspicious lesions previously detected on mpMRI simultaneously. Biopsies can then be directed straight to these mpMRI-visible targets with ease and accuracy under real-time ultrasound guidance.
Improved Cancer Detection
Several large prospective clinical studies have now demonstrated the superior detection rate of fusion biopsy compared to standard biopsy alone for detecting clinically significant prostate cancer. In one study of over 500 men undergoing their initial biopsy, fusion biopsy detected 29% more high-grade prostate cancers and 38% more clinically significant cancers than standard biopsy. Additionally, studies have shown that approximately 20-30% of men avoid unnecessary repeat biopsies after an initial negative standard biopsy by using MRI targeting with fusion biopsy up front. This allows for improved certainty in diagnosis and avoids subjecting men to unnecessary repeat biopsies and the risks associated with those procedures when cancer is actually not present. The improved detection and avoidance of unnecessary repeat procedures are two major advantages conferred by fusion biopsy technology compared to traditional biopsy methods.
Defining Clinical Significance
One challenge of prostate MRI is accurately defining what MRI findings represent "clinically significant" cancer versus lower risk lesions that may not require immediate treatment. Several clinical and MRI-derived factors have been associated with higher Gleason score cancers that may warrant more aggressive workup and management. For example, lesions measuring over 0.5cc in volume, with higher apparent diffusion coefficient values on diffusion-weighted imaging and rapid contrast enhancement kinetics on dynamic contrast-enhanced imaging have all been linked to more aggressive disease on pathology. The PARAGON study demonstrated that MRI-visible lesions meeting at least two of these criteria represented clinically significant cancer over 90% of the time on template mapping biopsies. Ongoing research aims to further refine MRI parameters that define higher grade disease to improve risk stratification and guide management decisions following a multiparametric MRI.
Is Fusion Biopsy Better Than a Repeat Biopsy?
For men who have previously undergone a negative standard biopsy but are still clinically suspected of having prostate cancer, fusion biopsy provides improved accuracy over repeat standard biopsy alone. One study directly compared MRI-targeted fusion biopsy to repeat standard biopsy alone in 340 men following an initial negative biopsy. Fusion biopsy detected five times as many high-grade cancers as repeat standard biopsy (27% vs 5%). Another study that only included men with negative biopsies found fusion biopsy detected high-grade cancer in 28% versus only 8% for repeat standard biopsy. These studies confirm the clear superiority of MRI/US fusion targeting over repeat standard biopsies without MRI targeting when the initial biopsy was negative but there remains clinical suspicion for disease. Fusion biopsy helps avoid unnecessary repeat biopsies and provides improved cancer detection in this important group of men being evaluated for potentially missed prostate cancer.
Steps to Implement Fusion Biopsy in Your Practice
While fusion biopsy represents the new standard of care, its adoption into clinical practice requires significant investments. Providers interested in adopting this technology must take several important steps:
1. Obtaining a fusion biopsy system requires purchasing specialized hardware including an electromagnetic tracker, fusion software, biopse gun/needles, etc. Costs can range from $150,000 to $250,000.
2. Hiring a dedicated technician to assist in image registration and perform quality control is recommended.
3. Physicians performing biopsies require training to learn the software, understand MRI targets, and safely perform targeted biopsies under real-time fusion guidance.
4. Dedicated MRI sequences and radiology expertise is needed for accurate image acquisition and prostate lesion identification on mpMRI.
5. Reimbursement must be obtained for the additional pre-biopsy MRI and time/expertise required for fusion targeting.
6. Quality assurance processes should be developed to monitor outcomes and ensure optimal patient selection, performance of fusion biopsies, and tracking of histopathological results for reporting.
In the implementing a high-quality prostate MRI and fusion biopsy program requires multidisciplinary collaboration and significant investments but has great potential to improve prostate cancer diagnosis and management through improved detection of clinically significant disease. As the data continues to mount, fusion biopsy will likely become the new standard of care for men undergoing initial or repeat prostate biopsies. The future of prostate cancer diagnosis lies in combining the strengths of MRI with real-time ultrasound fusion guidance.
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Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc. (https://www.linkedin.com/in/money-singh-590844163)
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