Transurethral Ultrasound Ablation (TULSA) for Prostate Cancer Treatment: An Interview With Joseph J. Busch, Jr., MD

Dr Busch is the owner of the Busch Center, an imaging center in Alpharetta, Georgia that is dedicated to the diagnosis and treatment of prostate cancer. He spoke with IO Learning about integrating the recently FDA-approved TULSA treatment into his practice.

Tell us about the Busch Center, and describe your “Visible Radiologist” philosophy.

I’ve been in medicine for over 50 years (53 including medical school). As complicated as medicine is, the most important thing a doctor can do is to listen to the patient, and then talk to the patient. Radiology has traditionally been a “closet” position. In other words, the radiologist sat in a room alone and interpreted pictures. The only people I spoke with were the referring physicians. Then I got into interventional radiology, and it changed the picture. Interventional radiologists interact with patients and perform biopsies and drainages. So, we need to interview with the patient, introduce ourselves, and explain the procedures. This change started in the late 70s; in 1977, my job every day was to catheterize brains. I was inserting a needle or tube into a patient’s blood vessel to study the brain or spinal canal, and death was a possible outcome, so it was important to meet the patient and their family. I became very accustomed to interviewing patients and explaining their procedures. As the years went on, I never stopped this practice, and in 2009, my MRI prostate training with Professor Jelle Barentsz (Netherlands) began. When cancer patients come in for imaging — particularly patients who are undergoing continuing therapy, which can last for many years —  they really want to know what’s going on as soon as possible. They don’t want to wait several days for a dictation; they would like to know the results the same day, and once I started doing cancer imaging, that’s exactly what I did. The patients absolutely love it, and it was a boon to our business, because very few places offer same-day results. 

I’m a member of the International Cancer Imaging Society (ICIS), and attended our conference in Menton, France a few years ago. The president of ICIS, Professor Mu Koh (London, England), gave a lecture on the future — what should the future of radiology be? He suggested that the most important thing we could do was to become visible radiologists. In other words, instead of sitting in a back room and reading a scan, particularly in the world of cancer, we should get involved with our patients, because we make the decisions about what is happening with the patient’s cancer as far as whether the patient is getting better or getting worse. So this was the first time I heard the term “visible radiology,” and I realized that I’d been a visible radiologist for almost 10 years. 

In 2010, no insurance company would pay for a prostate magnetic resonance imaging (MRI) scan. Patients were offering thousands of dollars and asking me to do the scans and read them. I said, sure, I can do that, but if I’m going to do the imaging, why not come into the office and sit on the couch, and we can talk about it and I’ll show you the results? The patients absolutely loved it. However, radiologists can’t do this in private practice, because insurance companies won’t pay radiologists to speak with patients. If they speak with every patient they see, the practice will go bankrupt. The only way to succeed financially is to use a cash program or some sort of foundation. Some of my earliest patients suggested building a private clinic where it would be possible to charge for the consultations, and I believe our patients think that what we offer is well worth the money. Granted, there are many people who are unable to pay the price, and we do a lot of charity work as well. My investors often tell me I do too much charity work, and I understand we have to pay the bills, as we have some very sophisticated, expensive equipment here, but we also like to help out when possible. 

The bottom line is that the Busch Center has always used a visible radiology approach. Our clinical team consists of myself; Kathy Busch (my wife), BS, RT (N), (CT), (MRI), CNMT (PET), who has worked in radiology imaging and education for 38 years; and Roland Rose, our Imaging Specialist. Our team ensures that each patient who comes here is fully educated about their diagnosis and therapy options and receives personalized care. We think it’s important to talk to patients before we do MR therapy or invade their space with a biopsy. At some hospitals, the patient is put to sleep and doesn’t ever meet the person who does the procedure, and that can be very upsetting to patients.

What diagnostic procedures are offered at the Busch Center?

We do two types of diagnostic MRI for the prostate. The first is a screening biparametric MRI,  which is a new type of MRI that doesn’t use intravenous contrast media. It’s a way to screen the prostate with no needles, no contrast media, and no radiation. This procedure requires an expert-level radiologist. In other words, the radiologist needs many years of experience, and must read at least 1000 scans/year (which I easily do). It takes years to get to this point; even today, I see cases that I’ve never seen before; in my opinion, they are very difficult and could not be handled by an inexperienced radiologist who is unable to determine if it’s significant cancer or not significant cancer. 

The second diagnostic test we do is called a multiparametric prostate MRI. This test uses IV contrast media, and is mandatory in patients who have had prior therapy for prostate cancer (prostatectomy, radiation therapy, some time of focal therapy, etc). Multiparametric means that in addition to anatomic imaging, there is functional imaging. Part of the functional imaging is injecting the IV contrast media and studying the flow of media through the tumor. For example, images are taken every 6 seconds (with some new techniques using images every 3 seconds) to examine the dynamic character of the tumor. 

The Busch Center also offers whole-body MRI, advocated by Professor Anwar Padhani (London, England), which is done to determine staging of the disease in cases of high-risk prostate cancer. There are certain cancers where the patient is at extreme risk to have metastatic disease somewhere in their body — either a lymph node or a metastasis to an organ or a bone. Whole-body MRI is superior (by at least 30%) to the standard of care in America, which is the bone scan and computed tomography scan. 

Last, we offer MRI in-bore targeted biopsy with ADC mapping. This is the most accurate prostate biopsy method available, and I’ve done thousands of them since 2010. This method is used to locate a lesion and perform a biopsy while the patient is in the MRI scanner. I’m able to first use a guide needle and pinpoint the exact location of the cancer in two planes. Once I’m at the precise location, I carry a titanium needle into the room and do the biopsy; I take a picture of the titanium needle sitting within the cancer. The genomic pattern of tumors offer important information, and the MRI can actually tell the radiologist where the different kinds of cancers are in the prostate gland, based on the diffusion attributes of the water molecules in the tissue. For example, when the cancer is dehydrated, with all of the cells packed in tightly with each other, the water doesn’t move very well. Whereas if you’re within a normal gland, it moves as it would in a bladder, with water moving all over. We can think of the prostate gland as a water factory, surrounded by pipes. The cancer either occurs in the factory or in the pipes, and the pipe cancers are much more dangerous to the patients. Prostate cancer is heterogeneous and I can identify the worst parts of the cancer. For example, if I’m looking at a 15 mm lesion, but only 5 mm is made up of Gleason 4 or 5, then I can see that on the MRI, and I’m going to stick that part of the tumor. A urologist, on the other hand, does  a fusion biopsy. I can set the target with my MRI remotely, and then send that image to a remote urologist, who “fuses” it to their ultrasound machine, but they’re not looking at the tumor live and in real time like I can do. There will be misregistration using the fusion method, and Gleason 3 cancers will be missed. Fusion biopsies are more accurate than traditional truss biopsies and cognitive biopsies, but not as accurate as the in-bore targeted biopsy at the Busch Center. I’m are able to biopsy the worst genomic part of the cancer and target that area, leading to better outcomes with fewer side effects.

Tell us about the treatment options at the Busch Center.

We offer treatment options such as focal laser ablation or the TULSA procedure. Some patients may require aggressive treatment options such as radiation or surgery, which are done elsewhere. 

Tell us more about the TULSA technology for prostate cancer. 

TULSA  stands for Transurethral ULtraSound Ablation, and is sometimes called “inside-out” ablation. The TULSA technology has been around for about 10 years. Profound Medical designed the technology for the treatment of prostate cancer, and proof of concept was done years ago. Researchers first used animal models to demonstrate that they could use this device to shoot a high-intensity ultrasound beam from inside the urethra to inside the prostate gland to kill the cancer, and then proved the same thing in human studies. After the treatment, they removed the prostates surgically and demonstrated that the cancer was gone. 

After they finished the proof-of-concept trials in animal trials and phase 1 trials in humans, they expanded the trials around the world to several universities. They treated the entire gland with TULSA, and compared it with prostatectomy, with 4-year data now available. First, they’ve shown that they can kill cancer with this technique. Second, and very importantly, they’ve shown that 90% of the men who had sexual function before the procedure retained their sexual function afterward. In addition, 98% of the men who had no urinary incontinence before the procedure maintained bladder control afterward, so the toxicity of the TULSA procedure seems to be less when compared with prostatectomy. The phase 2 trial results were therefore very promising, so the FDA approved the use of TULSA in America. We are one of only two sites in the United States to offer this procedure, and just finished our first week. I did 4 procedures the first week, with 4 scheduled the second week, and 4 scheduled for the following week, with more coming. We are the first site in the world to do this procedure without general anesthesia, which means no intubation. This was executed by our CRNAs with the use of MAC (managed anesthesia care) and with MPM (multimodal pain management). The first 4 patients turned out beautifully; they were all happy. These patients are able to leave the office with a catheter in place for only a few days. Of course, we don’t know the results out to 6-12 months, but the procedures themselves went well. 

We’ve executed the fastest TULSA procedures in the United States. The first United States case took 6 hours, while our first case took 3 hours, and the others took 2 hours. I anticipate that we’ll be able to reduce our time further once we’ve refined our techniques. The bottom line is that these patients go home the same evening, and their cancer has been treated. 

Kathy and I saw this technology in Europe with Dr Jurgen Futterer (Netherlands), years ago and were very impressed with it. We started to take patients to Europe to get the procedure. The university that taught me about prostate cancer techniques was the first in the world (to my knowledge) to treat only the cancer, rather than the entire gland — they only treated a third of the gland, or half of the gland, etc. However, all of their procedures used general anesthesia and all patients had to spend the night in the hospital. I thought we could offer patients less anesthesia and a shorter length of stay, and that’s what we’ve been able to do. We’re very excited about the procedure, but again, we will be closely watching the outcomes at 6 months, 12 months, and out to 5 years. One exciting thing we’ve seen in Europe is that if the cancer comes back even after focal therapy, the radiologist can re-treat it focally. For example, if we picture the cancer as a pie, and a 1/8th piece of the cancer comes back, we can either perform TULSA again or use focal laser ablation. A soon-to-be-published study from California has shown that the patient is much better off after multiple focal treatments than if the patient has a recurrence of cancer after a prostatectomy or radiation therapy. Quality of life is higher after TULSA or focal laser ablation.

Are there any contraindications to the TULSA procedure?

There are patients who aren’t good candidates for TULSA. If the patient has extensive local disease — in other words, if the cancer is growing out of the prostate and up into the seminal vesicle, diaphragm, sphincter, etc., then I don’t think the TULSA treatment would be helpful. In those cases, more traditional treatment like radiation therapy would be more appropriate. Surgery wouldn’t necessarily be a good option, so radiation would be the best hope for a cure. 

Radiation to the whole gland does work well for localized cancers, but usually entails daily treatments for 5-8 weeks, with at least a month or two of chemical castration from the hormone therapy. In contrast, the TULSA technique treats the entire gland in a few hours, and the patient goes home that night. Even if the patient does have metastatic disease, I can foresee value in teaming up with other practitioners. For example, if a patient had positive lymph nodes, the entire prostate gland could be treated with TULSA on one day, followed by spot treatment of the lymph nodes with radiation over a 1-week period. The patient would be done with all of their treatments in a week as opposed to 6 weeks. So I think there are a lot of future potential uses for the TULSA technology. The company that developed TULSA (Profound Medical), is excited about potential use of the technology to treat benign prostatic hypertrophy, essentially shrinking down the enlarged gland. The current European trials are already running, so we’ll have to wait to see those results. TULSA may be a good way to shrink the prostate gland, but I’m interested to see the results and possible side effects. So far, the European results have shown promise that TULSA will be an excellent treatment for an enlarged prostate gland.

TULSA is also promising for patients who have recurrent prostate cancer after radiation treatment. MRI can locate the exact location of where the cancer came back in the gland, and TULSA can treat the precise spot. We haven’t done any of those cases yet, but we’re looking forward to it.

Are there any drawbacks to TULSA?

The main drawback is that it requires a dedicated clinic like ours, or a facility that is willing to shut down their MRI for 3 or 4 hours in order to do this procedure. From a cost perspective, a hospital is going to want to do 5 MRI brain scans instead of a TULSA. The Busch Center, on the other hand, is a dedicated prostate MRI (Figure 1) — that’s what we do. Our clinic’s goal is to offer full screening, diagnosis, and full focal treatment. 

Will the role of focal laser ablation change once you’ve fully integrated TULSA into your practice?

Focal laser ablation supports the TULSA technology. It’s been around for 12 years, and it works very well. I’ve seen hundreds of patients get focal therapy with great success. However, it’s more appropriate for smaller lesions.  

Any final thoughts?

We had very good results with TULSA technology in our patients who traveled to Europe for treatment, so we were very excited to get started here in the United States. We embarked on the use of TULSA quickly because we did not think it would receive FDA clearance for another few years. When we heard it was approved, we wanted to try our own techniques, which I would term “partial-gland therapy” — treatment of a third of the gland, half of the gland, etc. In other words, we’re taking what has been proven with whole-gland therapy, and attempting to provide excellent results with partial-gland therapy. 

Now that I’ve performed the technique myself a few times, I’m very happy with the overall procedure. I was also pleasantly surprised by the patients’ responses. They had only nice things to say about their experiences. However, the proof will be in the outcomes. The research outcomes on whole-gland treatment were positive, and we eagerly await the partial-gland treatment outcomes.

Disclosure: Dr Busch has completed the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Busch reports no conflicts of interest regarding the content herein. 

Address for Correspondence: Dr Joseph J. Busch, Jr., Busch Center, Brookside Concourse 100, 3650 Brookside Pkwy Suite 175, Alpharetta, GA 30022. Email: contact@buschcenter.com