Prostate Cancer: Fusion Biopsy

NEW YORK. (KFSN) -- For decades, doctors have diagnosed prostate cancer using what's been called a 'blind' biopsy, removing and testing a dozen tiny tissue samples to see if cancer is present. Now, new technology is taking the guesswork out of the procedure by allowing doctors to precisely target suspicious areas where deadly cells may be lurking.

High-tech images and an electromagnetic tracking system, like GPS for the body, work together, giving doctors more information than ever before.

Arcenio Miller has prostate cancer. But he feels good knowing that doctors have a very clear picture of his condition. Miller told Ivanhoe, "More lesions came out and more spots were detected."

Doctors found cancer in an area of Miller's prostate that would not have been targeted by a traditional biopsy, using a system called UroNav.

UroNav fuses together a patient's MRI and ultrasound to create a highly-detailed 3D view of the prostate.

Art Rastinehad, D.O., Director of Focal Therapy and Interventional Urologic Oncology and Associate Professor of Urology and Radiology at Icahn School of Medicine at Mount Sinai said, "We're able to guide the needles in the treatment area and just focus on that specific spot."

Dr. Rastinehad inserts the needle precisely using this computerized grid. He does the biopsy by going through the skin.

"The infection rate is much lower in this approach because we are not going through the rectum," Dr. Rastinehad explained.

Miller suffered an infection after an earlier traditional biopsy. For him, this technique was a relief and may bring him one step closer to good health.

"Thanks to good doctors that I have been able to meet and that have been able to treat me, give me assurance that I will be cured from this disease," Miller said.

Dr. Rastinehad says between two and seven percent of all men who undergo traditional biopsies will get an infection. With the UroNav and a biopsy through the skin, the rate is less than half of a percent.

Prostate Cancer: Fusion Biopsy -- Research Summary

BACKGROUND: There are approximately 220,000 new cases of prostate cancer diagnosed each year, according to the American Cancer Society. The disease mainly occurs in men 50 years of age and older, but has, on rare occasion, appeared in men under 40. African-American men tend to develop prostate cancer more often than other races and they are twice as likely to succumb to the disease. There is some research suggesting a genetic factor may be involved in the cancer, and men who have a father or brother with prostate cancer have double the risk of developing it. Prostate cancer is considered the most common cancer found in men in the United States. The disease affects the prostate, a gland found in men that sits just below the bladder. There are many types of tumors that can be found in the prostate but prostate cancer is usually an adenocarcinoma, a cancer that is formed in the gland cells. (Source: http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-what-is-prostate-cancer, http://www.cancer.gov/types/prostate)

TREATMENTS: There are several treatment options for patients with prostate cancer. The treatment plan chosen depends on the stage of the disease, the patient's other health issues and patient's personal feelings about the side effects of each option. Treatments include:

Watchful waiting: This treatment is a monitoring of the cancer through further testing and exams to see if the cancer is spreading. Older men with other medical conditions are usually prescribed this course of treatment in order to avoid invasive surgery.

Surgery: Many prostate cancer patients who are otherwise healthy may have a surgical procedure to remove the tumor. Surgery could involve removing the prostate or the lymph nodes to relieve the symptoms of the cancer. There are several complications that can arise from surgery, including impotence, hernia and bladder leakage.

Hormone therapy: Because prostate cancer is formed in the glands, hormone therapy may help stop the cancer cells from growing. (Source: http://www.cancer.gov/types/prostate/patient/prostate-treatment-pdq#section/_142)

NEW TECHNOLOGY: Ardeshir "Art" Rastinehad, D.O., Associate Professor of Urology and Radiology at Icahn School of Medicine at Mount Sinai in New York, and his team have begun using a new imaging technique in order to identify suspicious areas in the prostate that may lead to cancerous tumors. The UroNav system is a MRI-ultrasound fusion biopsy procedure that uses real-time ultrasound images and MRIs of the patient's prostate to help guide urologists in biopsy procedures. Dr. Rastinehad said that 70 percent of patients who have a traditional biopsy receive negative results, however about 55 percent have clinically significant cancer. The fusion biopsy procedure is able to reduce the amount of false negative results and reduces the possibility of the patient having a second biopsy. (Source: http://urologytimes.modernmedicine.com/urology-times/content/tags/art-rastinehad/mri-guiding-future-prostate-cancer-diagnosis?page=full)

Prostate Cancer: Fusion Biopsy -- Doctor's In-depth Interview

Art Rastinehad, D.O., Associate Professor and Director of Focal Therapy and Interventional Urological Oncology at Icahn School of Medicine at Mount Sinai talks about a new technology in fusion biopsy procedures for prostate cancer.
Interview conducted by Ivanhoe Broadcast News in September 2015

What is an interventional urologist?

Dr. Rastinehad: So I spent my fellowships trying to bridge the gap between urology, urological oncology and interventional radiology. Interventional radiology utilizes minimally invasive image-guided techniques that we can apply and use on our patients to hopefully improve treatments as well screening for prostate cancer.

When there is suspicion of prostate cancer, could you explain for our viewers, some of whom may be familiar, what is the process right now in terms of biopsy and screening? How do patients go through that process?

Dr. Rastinehad: Typically, if the patient is concerned about prostate cancer and prostate cancer screening, we have a discussion. We discuss the pros and cons of screening itself. Once a patient decides to move ahead with screening, there are several options available. You can choose to follow your PSA. If the PSA becomes elevated, then we may recommend a biopsy or some intervention. Typically in the past, for the last thirty years, we've done biopsies under ultrasound guidance where we track regions within the prostate and place needles evenly spaced to hopefully optimize our cancer detection, but there is no real targeting going on at all.

Can you explain to our viewers what is actually happening, I don't necessarily want to call it a blind sample but what is happening with that traditional way of doing a biopsy?

Dr. Rastinehad: The traditional biopsy, colloquially known as a blind biopsy, means we just use ultrasound to make sure that we're able to evenly space our needles. The sensitivity and specificity of detecting tumors is pretty low and that's why we're not able to target suspicious areas within the prostate.

What is the risk of doing that? What could you potentially miss when this is done this way?

Dr. Rastinehad: First of all, the prostate biopsy only samples less than one percent of the prostate when done without targeting. The imaging that we have today, specialized MRI, can look at 100 percent of the prostate and, hopefully, help us and guide us to areas that may be missed with a standard biopsy.

I want to talk a little bit about the new technology, can you give me an overview of what is this machine, what does it do?

Dr. Rastinehad: It's actually two parts. First is our high quality imaging. You must have high quality prostate MRI images to use on the new machine. The machine takes the information from the MRI gantry where the MRI was done and brings it into the urologist or interventional radiologist office to allow us to perform the biopsy. That information is merged with the live ultrasound images that we obtain. Ultrasound is nice because it is inexpensive and it's real-time so you can see what's going on. But it can't see inside the prostate as well as an MRI.

Now, when you're looking at those images and you say it's merged, can you describe that a little bit more?

Dr. Rastinehad: Sure, when the images are merged or fused together, we take the benefits of both studies so they're overlaid, essentially. The MRI information is placed on the ultrasound and, during real-time, we will target those specific areas within the prostate.

For this particular machine can you tell me a little bit about this procedure?

Dr. Rastinehad: This machine, the transperineal MRI-ultrasound fusion guided biopsy technique is done in the radiology suite or an outpatient surgery center. We place the patient under anesthesia. Then we obtain ultrasound images the prostate. Once that is completed, instead of the traditional transrectal biopsy, we're able to go through the skin, which has a lower infection rate and no rectal bleeding compared to the transrectal biopsy.

Specifically, in patients when they had an infection after their first biopsy, they're very hesitant to go on to have a second biopsy. The infection rate is ranges between two to seven percent and with the transperineal biopsy the infection rate is <1% and you only get antibiotics at the time of the procedure and that's it.

Why is that important? I think as physicians we have to look at using antibiotics as a resource and are we using it up. We're creating drug-resistant organisms every day by overprescribing antibiotics.

So it is definitely a benefit to the patients who have had infections before. Could you list some of the other benefits?

Dr. Rastinehad: The benefits of doing a biopsy transperineal is you have a lower infection rate, you have no rectal bleeding and it also allows us to plan in the future, in special cases, where there's cancer only found in one spot. We may be able to go back to that spot and treat just that area, saving the man the complications of whole gland prostate cancer therapy, which can be erectile dysfunction and/or urinary leakage after treatment.

Let's talk about that targeted therapy, what is the common treatment now? What happens when a man goes through the prostate gland treatment?

Dr. Rastinehad: Typically, there are a few groups of patients. First is the patient that may have low-grade, low-volume disease on diagnosis. Then the second group of patients may have clinically significant disease, which may need treatment because they may have a lethal cancer. They undergo whole gland therapy which is radiation and/or surgery. And their associated complications, of course, are always a risk of leakage of urine or poor erections after treatment.

Then, we're looking at a group of patients that aren't exactly candidates for active surveillance and may not need whole gland therapy or have bad disease. They just have one focal area and do they really want their whole prostate out? So we're very excited here at Mount Sinai to be evaluating a new technology, we're able to just ablate that specific area using new transperineal MRI fusion technology. We're able to guide the needles in the treatment area and just focus on that specific spot.

So for example, a man before who was under active surveillance may actually be able to have some treatment, can you speak to that?

Dr. Rastinehad: When you're diagnosed with prostate cancer, there's a certain level of stress, but as physicians, we try to reassure patients that they may not have bad disease or they may not need treatment at all. However, there's a gray area, so patients with Gleason 3+4 or have a specific lesion on MRI, they just don't want cancer. 'I want it out' and we're evaluating an investigating a new approach called focal therapy, or we like to call it the middle way. So you're not going towards full treatment but maybe we can treat this area and then watch you over a period of time using this high end multi-parametric MRI imaging, as well as targeted biopsy to make sure we're able to treat that area and follow that area in the future.

The focal therapy that you are talking about is that in clinical trial right now or is that already being used in clinical practice?

Dr. Rastinehad: Focal therapy itself is not considered a standard of care. We're considering that an investigational treatment. What we're really excited here at Mount Sinai is that we've collaborated with an outside company and we provide an ablation using gold nanoparticles that go to the specific areas of prostate cancer. And we're able to use a laser fiber to place it inside and excite those particles to destroy the tumor which is very exciting.

Is that soon-to-be, is that a Phase I?

Dr. Rastinehad: It's actually a Phase II trial. We've already completed Phase I and this is looking at if we are able to ablate prostate tissue effectively.

Is that trial opened for participants at this point?

Dr. Rastinehad: Currently, it's not open yet. We're in the final stages of opening the trial. Our goal is to have that open within the next month or so.

I'm going to ask you to take me through the process and what we would see on the screen.

Dr. Rastinehad: Typically, we take information from the MRI where we target the high-risk areas. That information is placed into the UroNav biopsy platform and we confirm the targeted locations. We look at relationships and other information from the MRI before proceeding through to the procedure. Once the information is placed we then obtain ultrasound images of the patient's prostate. And the computer merges them both together. Once they are merged together, we're able to perform a targeted biopsy of that region. What's also exciting is that we can actually track the standard biopsies to see if we did not catch something on the MRI. We can look back and see how we're doing, checking our work, for lack of a better term.

What do you technically see on the screen?

Dr. Rastinehad: Typically, we have on the top of the screen ultrasound images and that's our real-time information. And on the bottom screen was the prior, or the previously obtained MRI, that's the key information we use to target. So they are placed together and we use the information and the high risk area is actually laid on top of the ultrasound picture. And that is how we target specifically to that area.

How new is this technology? How long have you been using it and with what kind of success?

Dr. Rastinehad: The technology itself, the targeted biopsy or fusion biopsy, was developed at the NIH. They've been researching this since 2006. The most recent that was an FDA approved, or FDA cleared device, was UroNav for transrectal EM track biopsies. It was released about 18 months to two years ago. What's really exciting here is we performed the first transperineal EM track fusion guided biopsy. And that's through our research and development collaborations with Phillips Healthcare and Invivo. We are one of two sites in the country testing this, the other, of course, is the NIH.

Are there some patients for whom this is a better option than others?

Dr. Rastinehad: I think the benefit of this is the low infection rate. That's what we're very concerned about. Sepsis is a bad infection, so bad that you're admitted to the hospital and they give you long-term antibiotics. In some rare cases, it could lead to death. And that's why we're always concerned when we screen men for prostate cancer. We explain to them that there are these small but real risks that do occur.

And how is the infection rate lower with this procedure as opposed to the standard?

Dr. Rastinehad: The typical infection rate is quoted between two and seven percent. The infection rate for a transperineal biopsy is 0.5 percent. Some people in Europe have even stopped giving antibiotics because it's a percutaneous procedure. They clean the skin, they do the biopsy and you don't even use the antibiotics. Because what we're really concerned about is creating multidrug-resistant organisms. So I would say the best patients for this are the patients that had a complication on their initial biopsy.

Why is there less infection with this procedure? Is it because you're not going through the rectum, is that what causes the higher rate of infection?

Dr. Rastinehad: The infection rate is much lower in its approach because we're not going through the rectum. Because the drug-resistant flora within your colon are the ones that cause the infection and they do not respond to our typical antibiotics we use as prophylaxis during the procedure.

Is there anyone for whom this new procedure is not a good idea?

Dr. Rastinehad: Actually, it's up to the patient to choose between the different types of biopsy approaches after we have discussed the details. This does require a little bit more time and we're currently doing this with sedation. The transrectal approach is just done in the office, we numb you up like the dentist numbs you up before he works on your teeth.

Should this be the gold standard some day?

Dr. Rastinehad: The approach of a targeted biopsy is not part of the standard of care yet. I believe it performs better than a standard 12-core biopsy. However, all our current data is based on a standard staging. So typically, we provide a patient with extra coverage, we get the standard of care and then we make sure the highly suspicious areas are sampled using these target biopsy platforms.

Is there anything I didn't ask you that you want to make sure people know?

Dr. Rastinehad: I think it's important to understand this was the first transperioneal EM track fusion biopsy in the world. We have a long relationship with Invivo and Phillips Healthcare helping us evaluate and develop this new technology.

If you would like more information, please contact:

Art R. Rastinehad, D.O.

625 Madison Avenue

New York, NY 10022

212-241-9955

www.fusion-biopsy.com

Art.rastinehad@mountsinai.org