While all eyes have been on COVID-19, a positive trend in diagnosis and treatment of prostate cancer is underway at the country’s leading hospitals, hailed for their excellence in patient care, research, and education. Urologists at several leading hospitals in the U.S. have begun using an innovative new blend of precision technologies for diagnosis and non-invasive treatment of localized prostate cancer.

Used together, these devices — ExactVu™ Micro-Ultrasound (Micro-US) and Focal One Robotic HIFU (high intensity focused ultrasound) — detect even the smallest abnormalities for precisely targeted biopsies and then destroy precisely targeted prostate cancer cells. This is an exciting new alternative to more radical treatments using surgery or radiation therapy that treat the entire prostate rather than focusing on just the diseased area.  As a result, the risk of life-altering side effects such as urinary incontinence and sexual dysfunction are dramatically reduced.  This diagnosis and treatment protocol can replace costly MRI, and radical surgery and radiation for qualified patients, and is a game-changer with regard to men’s ability to recover quickly from these outpatient procedures and preserve their prostate.

Pin-point accuracy
The fact remains that the less tissue the urologist has to remove from a patient’s body, the better he will do post-treatment for prostate cancer.  This new generation of precision tools is purpose-built for prostate diagnosis and treatment, with pin-point accuracy, enabling the urologist to precisely diagnose cancer and non-surgically eradicate only diseased cells, while preserving the rest of a man’s healthy prostate and functionality.

Game changing technology – a cause for relief for many men

Using Micro-US for detection, doctors can now detect prostate tumors and other suspicious areas of the prostate with 300% higher resolution than standard ultrasound to find and grade cancerous tissue they wouldn’t normally see with standard ultrasound. One doctor likened detecting tumors with standard ultrasound to trying to drive a car blindfolded. Micro-US has removed the blindfold and replaced it with powerful magnification glasses.

Once the doctor has detected any tumors with Micro-US and diagnosed the grade and stage of cancer, he can use focal robotic HIFU, which fuses the high-resolution imaging and biopsy data with real-time ultrasound imaging.  This gives the urologist highly detailed 3D views of the prostate and lets him establish precise contours around the diseased tissue.  Focal robotic HIFU is programmed to “search and destroy” only that portion of the prostate using high-intensity ultrasound waves to destroy the diseased area.

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Breakthrough
What makes focal robotic HIFU stand out as a breakthrough in robotic therapy is its intelligence in carrying out the precisely targeted ablation.  The urologist first plans the navigation to the diseased area. Then, he enters the plan into the focal robotic HIFU system and automatically directs the probe toward the location of the tumor, destroys only this designated area, and adjusts as needed, in real-time.  The urologist can stop and readjust manually if necessary, so he is always in full control.

A urologist using focal robotic HIFU is similar to a pilot flying a commercial aircraft.  He first enters the flight plan and coordinates into the navigational system and the jet uses sensors and makes adjustments to fly safely to the chosen destination, with the pilot maintaining full control in case intervention is required.

Robotic surgery has made a tremendous contribution in the treatment of localized prostate cancer, and were removing the prostate is medically necessary. But for many men with more localized disease who are eligible, focal robotic HIFU would be an alternative to radical surgery.

These two precision technologies have changed what has previously been an unfortunate quality of life “sentence” for men.  They can avoid the disruptive side effects because they now can take advantage of this safe procedure through hospitals that are leading the way.

Another benefit of this protocol that is distinct from standard treatments in that it is repeatable, radiation-free, and safeguards the option for surgery or radiation if cancer ever returns. Whereas surgery and radiation cannot be repeated–once a prostate is gone or damaged from radiation, it is gone.

Research Underscores Positive Outcomes of HIFU
Soon this diagnosis and treatment protocol will become more prevalent in mainstream hospitals around the country. Demand will drive its adoption, as will more published research.

The Journal of Urology is scheduled to publish two pieces of research in October 2020.  The two studies performed by the University of Southern California (USC) Institute of Urology, Keck School of Medicine, and University of Miami Miller School of Medicine, both highlight favorable HIFU outcomes. Adding to numerous European studies, these are the first U.S. studies conducted that detail successful partial-gland ablation using HIFU.

“We are pleased to present this first and largest US study on focal therapy with HIFU as a primary treatment for prostate cancer,” said Andre Abreu, MD, Assistant Professor of Clinical Urology and Radiology, USC Institute of Urology, and first author of the publication. For the USC study, after two years of follow-up, 91% of patients avoided radical treatment, and its inherently debilitating side effects. Additionally, all patients maintained full continence and there was no significant decline of erectile function and no major adverse events occurred.

The University of Miami study included 52 HIFU patients between January 2016 and July 2018 and only one patient (2%) had to undergo radical prostatectomy surgery following the HIFU procedure. No change in continence was observed and sexual function returned to baseline at 12 months for all remaining patients. [1]

For Micro US, the Canadian Journal of Urology has published a study entitled, “Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicentered, prospective analysis,” and is scheduled for print in January 2021. This study of 1,040 patients at 11 medical sites in seven countries found a higher sensitivity, a higher Negative Predictive Value (NPV), and a similar Positive Predictive Value for Micro-US compared to mpMRI. The study shows, depending on test results from an exam with Micro-US, that men can feel confident in their decision to either proceed with a biopsy or to postpone it.[2]

For the first time, precision technology is making it possible for men diagnosed with localized prostate cancer to get a precise diagnosis and undergo a non-invasive, precise outpatient procedure that allows them to resume the life they love.

Clinical Trials
Urology San Antonio MRI/MicroUS Comparison – NCT03762616
Urology of Virginia Case Series – NCT03035487

Reference
[1] Nahar, B., Bhat, A., Reis, I., Soodana-Prakash, N., Becerra, M., Lopategui, D., Venkatramani, V., Patel, R., Madhusoodan, V., Kryvenko, O., Ritch, C., Gonzalgo, M., Punnen, S., Parakh, D. (2020). Prospective evaluation of focal high intensity focused ultrasound for localized prostate cancer. Department of Urology University of Miami Miller School of Medicine, Miami, Florida, Sylvester Comprehensive Cancer Center. The Journal of Urology, Sept. 2020. [Article]
[2] Klotz, L., Lughezzani, G., Maffei, D., Sanchez, A., Pereira, J. G., Staerman, F., Cash, H., Luger, F., Lopez, L., Sanchez-Salas, R., Abouassally, R., Shore, N. D., & Eure, G. (2020). Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicenter, prospective analysis. Canadian Urological Association Journal, 15(1), 1–13. [Article]

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