Prostate Cancer Diagnosis
Read about the differences between standard and fusion biopsy procedures and discover why Fusion Bx is better for your business.
Standard Biopsy Limitations
Detection of clinically significant cancer depends on two factors:
- Accuracy- how close to the truth a diagnostic test is
- Reliability- how reproducible a test is
Prostate cancer is multifocal and microscopic. Detecting it requires sampling at least a few cancerous cells in 10- 12 cores. It requires high specificity; you need to know where the cancer is and more importantly, where it is not2. The prostate remains the only organ where a blind sampling technique is standard practice. This is due to the poor visibility of cancer in 2D TRUS images and limited anatomical context to guide needles to suspicious locations in the 2D TRUS plane3. Despite these complications, most men are offered a standard TRUS biopsy based on an elevated PSA level or an abnormal DRE4.
Radiology and Urology Go Together
Fusion Biopsy Workflow
Why Fusion Bx?
"Focal Healthcare's Fusion Bx device offers a more practical and simplified fusion biopsy solution. It easily integrates into my workflow and furthers our work on active surveillance."
- Dr. Laurence Klotz, Sunnybrook Health Sciences Centre, Canada
Increased Detection Rates
The Bx has lead to cancer detection rates that are over 93% by addressing three key sources of inaccuracy during biopsy procedures:
1. Prostate Deformation
- Inconsistent pressure during the procedure leads to target error
- Freehand systems make it difficult to apply consistent pressure
- Focal’s semi-robotic arm prevents target errors by ensuring consistent pressure on the prostate
2. Patient Motion
- Patient discomfort increases motion
- Focal’s semi-robotic arm allows probe to pivot at patient’s sphincter for maximum comfort
- Automatic motion compensation accounts for minor movements
- Rigid only approach does not account for changes in shape and size of the prostate between image acquisition and biopsy procedure
- Prostate deformation can occur during procedure due to contact with probe
- Focal’s approach combines both rigid and non-rigid (elastic) methods:
- Rigid: Easily identifiable landmarks are used to align images in all three planes
- Non-rigid: A few simple contours are used to automatically segment the entire prostate and deform each slice
Fusion Bx 2.0 has FDA Clearance and is approved by Health Canada.
1 Bjurlin MA, Taneja SS. Standards for prostate biopsy. Curr Opin Urol. 2014;24(2):155-61.
2 Wei, JT. Limitations of a contemporary prostate biopsy: the blind march forward.Urol Oncol. 2010;28(5):546-9.
3 Harvey CJ, Pilcher J, Richenberg J, Patel U, Frauscher F. Applications of transrectal ultrasound in prostate cancer. Br J Radiol. 2012;85 Spec No 1 (Spec Iss 1):S3-17.
4 Kasivisvanathan, Veeru, et al. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. New England Journal of Medicine<. 2018; 378(19):1767–77. doi:10.1056/nejmoa1801993.