For more than a generation, the notion of lumpectomy instead of radical mastectomy for breast cancer was met with scorn and treated as heresy. Now, it is the standard of care and has saved the physical QoL for many women. Prostate cancer (PCa), which is similar to breast cancer in many ways, has also been considered not amenable to focal therapy as a form of lumpectomy. This is because of the size of the prostate, its relative inaccessibility, the fact that PCa is often multifocal, and concerns that focal therapy may rule out some treatment options if the cancer recurs. However, with the recent FDA clearance of high-intensity focused ultrasound (HIFU) in prostate disease, this therapeutic option has become viable. HIFU has been used for decades in Europe with excellent oncologic control and acceptable AEs.
The potential for prostate lumpectomies expanded notably in June 2018, which is when the FDA cleared the Focal One HIFU device as the first medical apparatus designed specifically for focal treatment of the prostate, although earlier devices made this procedure possible. As with all technological advances, long-term studies and clinical data will ultimately determine whether Focal One distinguishes itself as a uniquely useful instrument. Nevertheless, its arrival is significant due to the degree of precision with which diseased prostate tissue can be ablated while sparing healthy tissue and thus reducing AEs.
