Focal therapy for prostate cancer – robotic HIFU is available in Singapore

What is prostate cancer?

Prostate cancer is the 3 rd most common cancer affecting men in Singapore. Majority of men with prostate cancer patients do not have urinary problems or pain. They are diagnosed due to abnormal blood test called prostate specific antigen (PSA) and subsequent prostate biopsy that shows cancer cells.

What is focal therapy of prostate cancer?

Focal therapy uses strong energy that concentrates to destroy their specific targets. One of the energy sources is high intensity focused ultrasound (HIFU), which has been tested and approved for accurate and effective treatment of localised prostate cancer.

During the HIFU procedure, there are no radiation, no cutting and no surgical scars.

Advantages of focal therapy for prostate cancer using HIFU Since focal therapy using HIFU only affects the selected areas of the prostate, there is less chance of urinary incontinence and less chance of damaging the nerves for penile erection.

What is Focal One?

Focal One device is the robotic HIFU machine that was approved by US Food and Drug Administration (FDA) in June 2018 and subsequently by Health Sciences Authority (HSA) in Singapore. It uses the latest technology for precise treatment of specific prostate tissues without damaging non-target areas. Focal One also has capabilities for MRI-ultrasound fusion image processing, precision targeting with robotic-assisted control, safety features to
prevent overheating of rectal wall, and ability to check for adequate treatment using ultrasound and contrast-enhanced microbubbles.

Who may be suitable for Focal Therapy?
Prostate cancer patients who may be suitable include:

An Interview with Dr. Sam Peh, PanAsia Surgery Group on Focal-One HIFU treatment for Prostate Cancer

Prostate cancer is cancer that occurs in the prostate a small walnut-shaped gland in men that produces the seminal fluid that nourishes and transports sperm. It is one of the most common types of cancer in men and usually grows slowly. Prostate cancer that is detected early when it is still confined to the prostate gland has a better chance of successful treatment. Prime magazine has the privilege of speaking with Dr. Sam Peh of PanAsia Surgery Group to understand a little more about focal therapy and the latest prostate cancer focal treatment technology Focal-One that has been brought into Singapore. DR. PEH. TO BEGIN, CAN YOU TELL US WHAT IS FOCAL THERAPY? Dr. Sam Peh: Focal therapy is a form of localised treatment that treats where the cancer is in an organ, and you try to save or preserve the rest of the organ. So in the case of the prostate, by extrapolation, you are preserving the function of the prostate. It is an organ-sparing treatment. SO WHAT ARE SOME FORMS OF FOCAL THERAPY? IS FOCAL THERAPY AN UMBRELLA TERM? DSP: Focal therapy is an umbrella term. It is not a unique term to prostate treatment. It is used in many instances in medicine. One example of the use of focal therapy in urology is the usage of cryo-ablation to treat small kidney tumours. The concept is the same. You try to preserve the majority of the kidney, killing only the cancer cells and a little bit of the surrounding tissue. Focal therapy for kidneys has been around for quite some time. It is established and successful, achieving good results. Similarly, you have focal therapy for the breast as well, using cryo-ablation. There is also HIFU (High Intensity Focused Ultrasound) focal therapy for uterine fibroids, preserving the uterus. It is similar to the HIFU technology we will be talking about. Other forms also include gamma knife used for brain tumours. FOCUSING ON PROSTATE CANCER, FOR WHICH MEN WOULD FOCAL THERAPY BE AN APPROPRIATE CHOICE? DSP: To answer this question, we go back to the function of the prostate. The function of the prostate is to make semen. So for someone who wants to preserve their fertility, focal therapy would be a very good choice. The fact is that the prostate is located in a very strategic position: Right below the bladder, with the urethra going through the centre of the prostate and the two nerves that supply signals for erections going by the side of the prostate. So if one is to treat cancer in a radical way: Meaning taking away the cancer as much as possible by removing the prostate, beyond infertility, it could also result in incontinence and impotence. This is because such surgery may damage the valve that controls the flow of urine as well as the

nerves that produce erections. This is where focal therapy becomes an attractive proposition. NOW MOVING ON TO FOCAL-ONE, CAN YOU TELL US A LITTLE MORE ABOUT THE FOCAL-ONE TECHNOLOGY AND DESCRIBE WHAT MAKES THIS ULTRASOUND TECHNOLOGY THE WORLD’S MOST ADVANCED PROSTATE ABLATION DEVICE? DSP: Focal-One is basically an amalgamation of mature and new technology: HIFU, robotics and advances in software where MRI information can be merged into real-time ultrasound. This concept allows doctors to appreciate in real-time exactly where the tumour is. MRI technology has come on in leaps and bounds in the last five years. Taking the MRI information and superimposing it on ultrasound, we are now able to see where the cancer is. This is then amalgamated with HIFU technology, a technology proven to be able to kill cancer cells and direct it accurately and focally on the affected area. The accuracy is supplied by robotics technology, a precision tool that is steady, precise and accurate. Using the hand, such accuracy will not be possible. That, in gist, is the concept of Focal-One: an amalgamation of old and new technology. This technology has enabled us to treat prostate cancer in a convenient, single-encounter process. WHAT KINDS OF RESULT HAVE WE SEEN WITH THIS TECHNOLOGY IN OTHER COUNTRIES SO FAR? HOW ENCOURAGING ARE THE RESULTS? DSP: Results have been coming out of Europe mainly. The Europeans are, traditionally, very receptive to HIFU technology, which started 20 years ago. Beyond Focal-One, there have been older machines about 10-15 years old that have been giving good results, even though these machines lack the characteristics of Focal One: Precise accuracy and real-time information. The results from these machines, in terms of 10-15 year cancer free survival, is comparable to traditional radiation therapy or robotic radical prostatectomy. In a nutshell, the results have been good. Focal-One is also very established in South America. In the last six months, the US have also started to embrace the technology. The response has been so positive that EDAP-TMS (the French producer of Focal-One) has set up an office in Texas to take care of the growing American market. In Asia, there are only two machines: One in Seoul and one in Singapore. HOW DOES FOCAL-ONE TREATMENT DIFFER FROM CURRENT TRADITIONAL TREATMENT METHODS? DSP: First off, Focal-One is a single-encounter treatment process as opposed to traditional radiation therapy, where you have to go for treatment approximately five times a week, for a duration of around six to seven weeks. This is because the body is unable to take a single large dose of radiation therapy and so this is cut up into smaller daily doses over a certain period. I am not discounting the effectiveness of radiation therapy, but the treatment process itself is not time efficient. Furthermore, as previously described, traditional radiation treatment is not an organ-preserving treatment, whereas Focal-One is. Focal-One helps to preserve the fertility of the patient,

which conventional treatments are unable to do. There is also a greater chance of side effects from conventional treatment processes, such as incontinence and impotence. Focal-One greatly reduces these possibilities. ARE THERE ANY DRAWBACKS OR POTENTIAL RISKS INVOLVED IN USING THIS TECHNOLOGY TO TREAT PROSTATE CANCER? DSP: I would say it is more of a psychological drawback. A lot of people are unable to grasp the concept of not treating prostate cancer radically. The belief is usually that if you have cancer, you must be as aggressive as possible in treating it. Some people may harbour doubts that if a cancer is focally treated, the cancer may not be completely eliminated and is still there. Some other people may not like the idea of leaving part of the prostate untreated, believing that there is a possibility of a new cancer growing in the remainder of the organ, despite the old cancer being completely removed.

To address this psychological issue, we need to look at the follow-up actions that can be used to detect any recurrence, if it happens. So what are the tools to followup a prostate cancer patient? The standard tool is a very convenient blood test called the PSA. Cheap at about $50, it can be reproduced anywhere in the world as the tool has been around for quite a while, so you do not have to worry the country of production. PSA is very accurate. Secondly, we can also fall back on the MRI. At the right time, we can always do an MRI when necessary and it can tell us the degree of suspicion of another cancer coming back. Thirdly, the prostate is easily accessible via biopsy. That means you can easily re-biopsy the remaining part of the prostate to establish if the cancer has come back. So the tools for follow-up are proven and widely available. In that sense, the

prostate is an ideal organ for focal therapy as after leaving prostate tissue behind, we can still easily follow-up with it and become aware quickly if there is recurrence. WHAT ARE THE COSTS INVOLVED IN FOCAL-ONE TREATMENT? DSP: The cost is likely to be around half or two-thirds of robotic surgery. It may be slightly more expensive than conventional radiation therapy, which costs around $25,000. The cost for Focal-One treatment involved would cover everything from professional fees, use of the FocalOne machine, hospital fees and any drugs that are needed. WITH PANASIA HELPING TO BRING IN THIS NEW TECHNOLOGY TO SINGAPORE, HOW SOON DO YOU THINK WE WILL SEE THIS TECHNOLOGY BEING ADOPTED AS A REGULAR TREATMENT METHOD FOR PROSTATE CANCER? WHAT, IF ANYTHING, NEEDS TO HAPPEN TO HELP BRING THAT REALITY TO FRUITION? DSP: I believe for focal therapy to be more widely used, there needs to be a cultural shift in thinking, as in, whether, some groups of people can accept new technology. This is difficult to predict. Also education of patients is important. If patients are aware of this option, know enough to bring it up during discussions with their urologists and want to use this treatment, I believe this demand will result in more doctors training to use the machine so they can offer this service. I believe this will then enable Focal-One to be a major success. And while Focal-One may not be a solution to all localised prostate cancers, it is definitely a solution to, at least, a segment of localised prostate cancer. WHAT HAPPENS IF A MAN USES FOCAL THERAPY AND LATER HIS CANCER RECURS? CAN HE GO ON TO OTHER SUBSEQUENT TREATMENTS? DSP: Yes, focal therapy does not preclude other types of treatment. And as previously mentioned, the prostate can be easily followed up through various means. If a recurrence is detected, say, 10 years later after the first focal therapy

you can always re-treat the remaining organ tissue using focal therapy, meaning the same HIFU technology can be used for a repeat treatment. This allows the patient to continue to preserve the organ and retain fertility. If the patient so decides, he can even choose to go for a followup radical (radiation, robotic or both combined) surgery instead. However, this would mean the patient+*

s fertility would not be preserved, not to mention other considerable potential side-effects, such as impotence and incontinence. ON AN ENDING NOTE, ARE THERE ANY OTHER THINGS THAT THE PUBLIC OUGHT TO KNOW? DSP: People ought to know that prostate cancer is unlike other cancers. It is a very slow growing cancer. In Singapore, we are likely over-treating a significant number of patients; over-treatment that may result in infertility and incontinence problems. In my opinion, this is a heavy price to pay. Bringing in focal therapy, such as Focal-One, that gives patients the reassurance that they have been treated and are able to continue living their lives normally; I think this is a major benefit of focal therapy for prostate cancer patients.

Dr. Sam Peh Oon Hui (MBBS, FRCS Edinburgh, FAMS(Urology)) is a Fellow of the Royal College of Surgeons Edinburgh and a Fellow in the Urology Academy of Medicine Singapore. He also underwent a Urological Clinical Fellowship in Westmead Hospital, Sydney, Australia. He joined PanAsia Surgery Group in 2007. Dr Peh specialises in treating disorders of the male and female urinary tract and the male reproductive system. His services include the diagnosis, medical and surgical management of a full range of urological problems, including andrology, erectile dysfunction and male infertility. He also specialises in providing laparoscopic surgery, especially in managing problems and cancers of the kidney and prostate. Dr. Peh graduated from the Faculty of Medicine at the National University of Singapore in 1989 and obtained his Advanced Specialist Training in General Surgery in 1995. He has led several research studies and contributed to several medical journals. He has also presented numerous medical papers at variety of scientific meetings in conjunction with other contributors.