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Focal One Therapy For Prostate Cancer

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Focal Therapy For Prostate Cancer: If It Sounds Too Good To Be True

Focal Therapy For Prostate Cancer Gives Patient Full Recovery, Fewer Side Effects

If you have been diagnosed with cancer that is contained within the prostate, you may be thinking:

Hey, theres just a spot of cancer that showed up on the MRI, or:

Only three of the needles came back with any cancer at all.

And this may lead you to think: Why do we have to treat the whole thing? Why cant I just get a prostate version of a lumpectomy?

Or: Why not just zap that one spot of cancer?

Wouldnt that be great?

This is called focal therapy just treating part of the prostate. In just a few seconds on the internet, you can see that theres a lot of this focal therapy out there, and it all sounds great! No erectile dysfunction or urinary incontinence! If your PSA rises, no problem! Treat it again! A lot of doctors are offering focal treatment, using methods including cryotherapy , high-intensity focused ultrasound , or even with highly focused radiation.

Theres just one problem with every type of focal therapy for prostate cancer, says University of Michigan radiation oncologist and Prostate Cancer Foundation -funded investigator Daniel Spratt, M.D.: I would say, strongly, that its experimental. Theres a very high risk of recurrence, usually within the first three years and it may increase your risk of side effects if you later need curative treatment. There is a reason it is not considered a standard-of-care treatment by most national and international guidelines.

Vice President Marketing And Reimbursement Hugo Embert

Mr. Embert joined EDAP in 2008 and has successfully led several key programs in Product Management, Clinical Operations, Marketing and Global Strategy. Through Hugos efforts in leading the Regulatory and Market Access strategy, the company achieved FDA clearance in 2018 and Reimbursement for the Focal One Robotic HIFU System in 2019. Prior to joining EDAP, Mr. Embert has managed Research and Development programs and launched different disruptive technology products in the medical and dental industry. Mr. Embert holds a Masters Degree in Engineering and Image Processing from CPE Engineering School in Lyon, France.

Focal Therapy For Prostate Cancer: Complications And Their Treatment

  • 1Department of Urology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
  • 2Department of Urology, San Giovanni Battista Hospital, University of Turin, Turin, Italy
  • 3Department of Urology, Medical University Innsbruck, Innsbruck, Austria
  • 4Division of Surgery and Interventional Science, University College London, London, United Kingdom
  • 5Department of Urology, University College London Hospital, London, United Kingdom
  • 6Department of Urology, Ludwig-Maximilians-University of Munich, Munich, Germany
  • 7Urology Unit, Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy
  • 8Department of Urology, University Hospital Frankfurt, Frankfurt, Germany
  • 9Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany
  • 10Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
  • 11Department of Urology and Pediatric Urology, Mainz University Medicine, Mainz, Germany
  • 12Department of Urology, Antonius Hospital, Utrecht, Netherlands
  • 13Department of Urology, University Hospital Essen, Essen, Germany
  • 14Division of Nuclear Medicine, IEO European Institute of Oncology Scientific Institute for Research, Hospitalization and Healthcare , Milan, Italy
  • 15Department of Urology, University Hospital Zürich, Zurich, Switzerland
  • 16Division of Oncology/Unit of Urology, Urological Research Institute, Scientific Institute for Research, Hospitalization and Healthcare Ospedale San Raffaele, Milan, Italy

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What Is The Outlook For Patients Who Receive Focal Therapy

While the use of focal therapy for localized prostate cancer appears to be a promising development in a number of ways, it is still considered investigational and not yet part of standard therapy. There are a number of reasons for this, as follows:

  • The criteria for selecting ideal candidates havent been fully agreed on. This is an important question because mistakenly using focal therapy in place of a more traditional treatment could allow a cancer to go under-treated.
  • The criteria for defining an index lesion still need to be agreed on.
  • The idea that the index lesion determines how the cancer will develop hasnt yet been proven.
  • The factors that define treatment success or failure, and the triggers for re-treatment still need to be determined.
  • The long-term effectiveness of focal therapy is unknown.
  • It isnt clear that all side effects are eliminated by using focal therapy.
  • Focal therapy doesnt allow for firsthand pathologic and biologic study of cancerous tissue, as can be done when using surgical treatment.
  • Focal therapy sometimes leaves behind untreated cancer, which could possibly raise the risk of more serious problems in the future.
  • The overall cost to the healthcare system may be greater for focal therapy than for standard treatments.

Last reviewed by a Cleveland Clinic medical professional on 01/26/2021.

References

Rationale For Focal Therapy

Prostate cancer: Focal One®, a revolutionary treatment

Focal therapies have an established role in the treatment of numerous malignancies, including those of the kidney, breast, and liver. The guiding principle of focal therapy and partial gland ablation is to provide an organ-sparing approach to preserve function while achieving adequate tumor treatment. Ablative techniques for prostate cancer include whole-gland ablation, hemi-ablation of a single lobe of the prostate, and focal ablation- in which a single dominant or index lesion is destroyed using targeted image guidance, such as mpMRI. Studies have shown that up to 86% of prostates have more than two cancer foci, with over 80% of patients harboring bilateral disease . However, the driving principle behind focal ablation is the concept that the index lesion is the primary driver of disease progression and metastasis, and thus destruction of this lesion can effectively mitigate the risk of spread . The combination of MRI-targeted biopsy and standard systematic biopsy further allows for improved detection of cancers, and may reduce the risk of under-staging, aiding with better selection of focal therapy candidates .

Figure 1

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Focal Therapy Treatment Options

At USC Urology, we offer a variety of noninvasive focal therapy options. Our experienced care team will work closely with you to understand each option and keep you in control of your treatment plan.

One focal therapy treatment option is cryotherapy, which targets and destroys prostate cancer cells using very cold temperatures. Another effective treatment option is high-intensity focused ultrasound , which uses ultrasonic waves to heat up and destroy prostate cancer tissue and tumors.

Vice President Service And Applications Tim Heyer

With more than 30 years of experience in Sales, Service and Clinical Operations in the Urology space, Mr. Heyer brings his solid expertise in leading the companys technical support and clinical training and applications. Prior to joining EDAP in 2015, Mr. Heyer held several successful leadership positions in Sales and Service as well as managing mobile service operations for HealthTronics and Boston Scientific.

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Quality Of Life Is An Important Endpoint

It is important to provide realistic expectations for men considering RP. Although RP is the best curative option for localized prostate cancer, disease recurrence does occur. Epstein and colleagues reported that the 5-year probability of biochemical recurrence following RP for men with biopsy GGG 1, 2, 3, 4, and 5 is approximately 4%, 12%, 37%, 52%, and 74%, respectively. Furthermore, RP is not without risk of long-term erectile and urinary morbidity. Haglind and colleagues reported on functional outcomes 1 year following over 2000 open and robotic RP performed in Sweden. The rates of incontinence defined by using two or more pads a day was 20% and 21% following open and robotic RP, respectively. The likelihood of an International Index of Erectile Function score decreasing to < 17 was 81% and 77% following open and robotic RP, respectively. Barry and colleagues reported similar results based on pre-operative and post-operative survey of RPs performed in the US Medicare population. Donovan and colleagues recently reported on patient-reported quality-of-life measures to compare functional outcomes between AS, RP, and RT cohorts as part of the ProtecT trial. As expected, men randomized to RP had greater compromise of urinary and erectile function as compared with AS or RT at all time points but had less bowel-related morbidity than the RT cohort.

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The Benefits Of Focal Therapy

Focal Therapy: Eligibility, Treatments, & Side Effects | Ask a Prostate Expert, Mark Scholz, MD

Traditionally, men with localized prostate cancer meaning it has not spread outside the prostate gland who do not opt for active surveillance are treated with surgery or radiation therapy. These approaches remove or radiate the prostate gland and can potentially damage nerves and urinary and bowel passages. As a result, they are often associated with side effects that impact sexual, urinary, and bowel function.

Focal therapy uses advanced imaging, such as ultrasound and MRI, to target the exact location of the tumor and minimize the impact of treatment on the surrounding, healthy prostate tissue and structures. As a result, it is less likely to cause erectile dysfunction, urinary incontinence, and bowel problems.

Because focal therapy does not treat the entire prostate, there is an increased risk that cancer may be left behind or may return. For this reason, regular follow-up appointments are required to monitor for cancer recurrence. If a tumor appears again, repeat focal therapy or another option may be recommended to treat the prostate cancer.

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After Focal Therapy Treatment

You may experience general soreness, burning, and/or light bruising in the days after your appointment. It is normal to see small amounts of blood in your urine for several weeks after the procedure. Your prostate may swell, which can make urination difficult. A temporary catheter can be placed in your urethra if your doctor is concerned about your urinary function. It can be removed during a visit with your provider within the following few days.

Follow-up appointments will help your care team monitor your healing. They may include blood tests, imaging tests, and prostate biopsy.

Duke University Hospital is proud of our team and the exceptional care they provide. They are why we are once again recognized as the best hospital in North Carolina, and nationally ranked in 11 adult and 9 pediatric specialties by U.S. News & World Report for 20222023.

Our Approach To Focal Therapy

At USC Urology, we are here to deliver a tailored prostate cancer treatment plan that is based on your needs. You will be carefully evaluated by a team of prostate cancer experts with experience in prostate cancer surgery, as well as focal therapy.

With advanced treatment options, like focal therapy, our world-class medical team will keep you informed and in control of your treatment plan every step of the way.

Make an appointment with USC Urology to meet with one of our focal therapy specialists. Our expert care team has the information you need and the answers to your questions. Together, we will help you take an important step toward treating your prostate cancer.

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High Intensity Focused Ultrasound

HIFU is delivered via a transrectal ultrasound probe, which allows visualization as well as delivery of energy to the prostate. HIFU utilizes ultrasonic waves which are absorbed by the tissues and are converted into heat, usually heating the tissues above 80 degree Celsius, resulting in coagulative necrosis, while the rectal mucosa is protected with a coolant. HIFU is best suited for prostates with the anteroposterior diameter < 40 mm and when there are no prostatic calcifications, however larger glands can be treated after transurethral resection of the prostate and cytoreduction. The focal length of most HIFU platforms is 4 cm.

Comparison With Standard Treatment Options

EDAP

Bates et al. performed a systematic review to evaluate the evidence for FT as a treatment strategy in comparison with the standard treatment options for clinically localized PCa. They included five comparative studies and ten systematic reviews. Majority of the systematic reviews included were heterogeneous studies with low patient numbers, most were uncontrolled single-arm case series, with no data on long-term outcomes and with significant limitations. Due to the low quality of the evidence with significant uncertainties regarding the effectiveness of FT in terms of oncological outcomes in comparison to the standard treatment options, they recommend FT to be ideally undertaken in clinical trials or prospective cohort and comparative studies to gather robust evidence so that clinical recommendations could be made. Shah et al. compared oncological outcomes of FT to radical prostatectomy form a prospective multicenter database and performed propensity score matched analysis. After matching, 246 patients were identified in each arm, and they included patients with Gleason 4 + 3, PSA < 20 ng/ml, and T2c. Oncological outcomes over the follow up period of 8 years were similar between the FT and RP and that for RP was 79% P = 0.12)). Table 1 includes primary studies comparing FT to standard treatment options such as radical prostatectomy, radiotherapy and active surveillance.

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Prostate Cancer Treatment Innovations Next Gen Focal Hifu

Prostate Cancer Treatment Innovations Next Gen Focal Hifu . The world of technology is constantly changing, and new advancements are being made every day. From Prostate Cancer Treatment Innovations Next Gen Focal Hifu, new technology is being used in a variety of ways to make everyday tasks easier and more efficient. And in in hifu aim a the 2010 material about for we comprehensive and- treatment review prospero The focal hifu between the was of published this conducted localized articles to evidence available systematic medline of crd42021235581- focal therapy database the summarise literature therapy language english methods primary review as pca- a

Less Invasive Prostate Cancer Treatment Receives Fda Clearance Hifu Prostate

Hifu Cost For Prostate Cancer Treatment From 9 300 7 Hospitals 116 Reviews

Prostate Tumor Treatment Hifu Ablation System Focal One Edap Tms Ultrasound Guided

Hifu Focal Therapy Procedure For Prostate Cancer Vision Medical

Hifu Focal Therapy Procedure For Prostate Cancer Vision Medical

Prostate Cancer Treatment Innovations: Next Gen Focal Hifu

dr. david silver discusses a new innovation in the treatment of prostate cancer called high intensity focal ultrasound or hifu.

How Do I Know Which Treatment Is Right For Me

Your treatment choices depend on the type of prostate cancer you have, test results and the stage of the cancer. The goal of treatment may be to cure you, control the cancer and help ease problems caused by cancer. Your healthcare team will talk through treatment choices, the goals of treatment, and what the risks and side effects may be.

While there are various prostate cancer treatment options, the UC Cancer Center recently adapted a way to personalize treatment plans even further.

One of the exciting, new innovations that were offering is genomic analysis of tumors, said Timothy D. Struve, MD, radiation oncologist at the UC Cancer Center and assistant professor in the Department of Radiation Oncology at the UC College of Medicine.

What these tests allow us to do is to look at the genes whats driving that tumor and that allows us to tailor the treatment approach to that patient.

In addition to the new focal therapies discussed in this article, physicians consider treating prostate cancer with:

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Focal Therapy For Prostate Cancer: Recent Advances And Future Directions

Alex Wang, Luke P. OConnor, Nitin K. Yerram, MD, Naveen Nandanan, MD, Michael Ahdoot, MD, Amir H. Lebastchi, MD, Sandeep Gurram, MD, Heather Chalfin, MD, and Peter A. Pinto, MD

The authors are affiliated with the Urologic Oncology Branch of the National Cancer Institute at the National Institutes of Health in Bethesda, Maryland. Mr Wang and Mr OConnor are research scholars, Drs Yerram, Ahdoot, Lebastchi, Gurram, and Chalfin are clinical fellows, Dr Nandanan is a resident surgeon, and Dr Pinto is an investigator and head of the prostate cancer section.

Corresponding author:

Introduction

Oncologic Rationale and Use of Magnetic Resonance Imaging

Current Practices

Focal Laser Ablation

Focal laser ablation has recently gained popularity as a focal therapy option for the treatment of localized prostate cancer. During FLA, a small laser fiber is inserted into the tumor via a transperineal or transrectal approach.20 Thermal energy discharged through the laser fiber rapidly heats the lesion, creating a homogenous, spherical area of coagulative necrosis with well-defined borders .21 Although the extent of tissue destruction depends on the temperature and duration of the treatment, it has been shown that irreversible cell damage and protein denaturation occur at approximately 60°C.22

High-Intensity Focused Ultrasound

Irreversible Electroporation

Cryotherapy

Future Directions

Imaging: 7-Tesla MRI

MRI-Guided Transurethral Ultrasound Ablation

Disclosures

References

Specific Type Of Focal Therapy

Surgeon Champions Laser Focal Therapy Prostate Cancer Treatment

HIFU : HIFU focuses the energy of sound waves to create heat and destroy cancer cells. Just like a magnifying glass concentrating sun rays to burn a hole in the paper. During the procedure, an ultrasound probe is inserted into the patients rectum while the patient is asleep from anesthesia. Guided by MRI and ultrasound 3D-images, the physician finds the tumor, plus the area to be treated, and delivers the energy aimed at the diseased tissue in the prostate gland. HIFU is a noninvasive precision treatment that spares healthy tissue and lowers the chances of negative side effects associated with radical prostate surgery or radiation, such as impotence, incontinence and bowel function disturbance. UChicago Medicine is the first medical center in the Midwest to offer and perform this procedure with the newest Focal One advanced robotic HIFU technology. This fills a significant treatment void for men with localized prostate cancer who find themselves in between active surveillance and whole gland treatments such as radiation or surgery. The treatment has been used for years in both Europe and Asia.

Urologists Ariel Shalhav, MD, and Scott Eggener, MD, answer questions about new treatment options for prostate cancer, including focal therapy and HIFU, as well as specialized care programs for men diagnosed with advanced prostate cancer or at high risk for the disease.

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What Are Promising Treatments Under Study For Prostate Cancer

High-intensity focused ultrasound is an approach to therapy that is presently approved for use in Europe, and is under study in the U.S. It uses high-intensity sound waves focused on the prostate gland to heat and thereby kill cancer cells. It should only be used as part of a research study . The safety, side effects, and comparative effectiveness of surgery and radiation therapy must be established.

Clinical trials are research studies being conducted to evaluate new treatments for prostate cancer. These include approaches such as HIFU, as well as modifications of surgical and radiation techniques, and new drugs and immune therapy approaches.

Video Transcript

Some men with early stage prostate cancer who previously had to choose between active surveillance and aggressive treatment with a greater risk for side effects, now have a new option for treatment: focal therapy.

Focal therapy is an overall term that refers to several minimally invasive treatments that target only the parts of the prostate gland where cancer is located. The goal of the treatment is to ablate, or destroy, the tumor and a safety margin within the prostate, while leaving the remainder of the gland intact.

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