Post PSA screening, the standard of care for prostate cancer diagnosis is a “blinded” 2D biopsy, wherein 12 random biopsy cores are taken from the gland under ultrasound guidance. The procedure is invasive, has extremely low sampling coverage, and its limitations due to a substantial false negative rate are well documented. Moreover, certain areas of the prostate gland [i.e., the anterior gland, transition zone and apex] are known to be under-sampled or not sampled at all at routine non-targeted biopsy and are now increasingly being recognized as areas that may contain clinically significant tumors.
A positive biopsy leads to a treatment protocol, which primarily involves surgical or robotic prostatectomy, radiation therapy or whole gland ablation, leading to quality of life issues such as incontinence, impotence, bowel problems and loss of fertility. These induce immense stress in patients and are a huge cost to the overall healthcare system from a disease management standpoint.
There is consensus in the physician and patient community that multi-parameteric MRI (mpMRI) has a significant role to play not only in diagnosis but also treatment planning, guidance and follow-up of focal therapy of prostate cancer. However, the mass adoption of mpMRI by community urologists is not feasible with the current economics and workflow challenges.
mpMRI warrants sending a patient to a radiologist (typically at an imaging center) either after a high PSA and/or after a negative biopsy with high PSA. Once the MRI scan has been interpreted, the annotated mpMRI is sent back to the urologist who then either employs an expensive fusion guided system or cognitively uses this information to guide a biopsy or intervention. As is evident, the workflow adds significant cost, time and complexity. Urologists might lose the patient to an interventional radiologist. Also, mpMRI scans, performed on 3T magnets or 1.5T magnets with ECR, are expensive, invasive, and lack standardized protocols.
We are changing the paradigm of prostate cancer care by allowing patients to be screened, diagnosed and treated by urologists in an outpatient setting, and by eliminating the complexity, costs and workflow issues associated with mpMRI and fusion guided procedures. Our solution is a suite of products including high resolution pelvic MR imagers, devices for image-guided biopsy and treatment, and automated software for tissue characterization.