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by Terry McCormick   |   December 19, 2018

Journey to Northwestern

I count myself as fortunate, even lucky, when I recently had a diagnosis confirmed of benign prostate hyperplasia (BPH). The outcome could have been very different, and far worse, as many men have personally experienced. This past summer, as I scheduled my appointment for the series of diagnostic tests in Northern Virginia, I had done enough research to recognize my potential risk factors for prostate cancer were there. I am almost 60 years old, for years I have been bothered my all the symptoms and hassles of BPH, and I have not slept through the night in years. Yet, for the past decade or more, my primary care physician (a wonderful and conscientious doctor) kept telling me I was too young to have BPH, my PSA tests were normal, and exams proved negative. About ten years ago, my physician and I agreed to a referral to a urologist. The results of the urologist assessment? I was “drinking too much water.” I was a long distance runner and was taught to push fluids to stay hydrated for training.

Several months ago my symptoms changed for the worse: some nights instead of waking two or three times, it was now hourly. As you can imagine, this was quite disruptive for my wife. I have never been one to shy away from medical evaluations or treatment; it was time to advocate for myself and get to the bottom of it (pun intended).

In the Fairfax, Virginia office my new and young urologist met me in the conference room with the results of my tests: yes, they confirmed I had BPH. He explained why the alpha blocker medicine was no longer working and then he proceeded to hand-draw a sketch of what the issue was with my enlarged prostate; prostate anatomy is divided into sections, or lobes – my median lobes had swollen into the bladder. That hypertrophic lobe in my bladder was acting, in his words, like a “toilet flapper” blocking the urethra. Nice, I have a toilet flapping prostate. I was even less pleased with the treatment options the urologist offered, again, he mapped them out in sketches.

It was true – I did not have prostate cancer – and for that I am grateful.  I facing a decision about the three treatment plans presented to me: 1) I could have the prostate surgically reduced (TURP); 2) use of a FDA cleared water vapor jet; 3) another new recently FDA cleared image guided mapping for treatment with laser. I did not like any of these options and the potential side-effects.

I consider myself fortunate because I have been in the medical device industry for 35 years and comfortable evaluating technologies and reading scientific clinical studies. While I am certainly not an expert, nor medically trained, I do have an awareness of alternative treatments.

I share my story with you because of the intersection of a new treatment for BPH and the promise of a potential staged treatment option for prostate cancer. It is called Prostatic Artery Embolization, or PAE.

Searching ClinicalTrials.gov I confirmed Northwestern Memorial Hospital in Chicago was still enrolling patients in a PAE study for BPH treatment. Northwestern is a teaching medical center which I hold in high regard and I personally know the principal investigator (PI) running the clinical trial. I contacted the trial coordinators and enrolled in the study. It is a cooperative research program between the Urology department and Interventional Radiology (IR) – more on this speciality later. This cooperation is rather impressive because the urologist does not perform interventional procedures and will have to refer their patients to the IR for PAE treatment. As a result the urologist will not receive the professional fees for the treatments I described earlier.

Let’s review how PAE works and what my treatment will be like. To put it simply, microscopic beads, called microspheres, will be carefully injected into the prostate arteries that supply blood flow to the prostate. Both the right and left hemispheres of the prostate will be treated. Over the next few weeks the lack of blood flow to the prostate will “starve” the parts of the organ blocked “embolized” with the microspheres. This will shrink the prostate with the goal of minimizing, or eliminating BPH symptoms over time. The clinical trial is being conducted to determine if this will work. If it does, the company sponsoring the clinical study will use the study results, if positive, to submit to the FDA for clearance for use of the microspheres to treat PAE.

Image courtesy of BTG | Interventional Medicine

The day before my PAE I will go to the urology clinic for a series of tests the researchers will use as my “before” treatment baseline. I will be tested again at intervals over the next year to compare “after” treatment. Next, I will report to radiology to get a CT scan – this is a very important step – to image the blood vessels and anatomy leading to the prostate, thus creating a road-map that will be used the next day. CT uses high concentrations of radiation which is one of the negatives of preparation for PAE.

My PAE procedure will be performed by an interventional radiologist. Radiologist are experts in reading CT, MRI, PET and X-Ray images and interpret them for other specialities. An interventional radiologist has completed an additional three-year IR fellowship to perform non-surgical, less-invasive procedures, often using real-time imaging such as X-Ray (fluoroscopy) to navigate small, flexible wires and catheters throughout the body to deliver devices and drugs for diagnosis and treatment.

Image of digital mapping of vessels for planning and guidance of embolization. Courtesy of Siemens Healthineers

To begin my PAE treatment, a mild sedative will be given, but I will be awake the whole time. Accessing my blood vessels to reach the prostate arteries will begin with a small ¼ inch stick in my right thigh groin (femoral artery), a sheath will be placed in the vessel as a small tunnel inserted to allow catheters to snake through to the target area. A risk interventional procedures have is the femoral artery access incision have a small percentage that result in a big bruise occuring, called a hematoma. As the interventional radiologist performs the PAE microsphere delivery he will be using real time X-Ray with a iodine contrast “dye” to illuminate and track the devices while using the CT images from the day before as the navigation guide. Microsphere particles will be injected into a both sides of prostate arteries lobes, confirmed with fluoroscopy. The femoral artery incision will be closed with a special artery closure device to stop bleeding. I will rest for a couple of hours in recovery room and walk back to my hotel.

Call me crazy, but this PAE procedure appealed more to me than the alternative treatments that require transrectal ultrasound and urethra access to the prostate. Think of it this way: well studied and less-invasive urological procedures are performed from “inside” the prostate to shrink the prostate, and investigative interventional procedures work from “outside” to shrink it.

How does my PAE procedure have any relevance to prostate cancer?

Microspheres have been studied and FDA cleared for treating uterine fibroids, liver tumors, arterial-venous malformations, and other vascular tumors for more than a decade. Interventions can be performed as an alternative to major surgery, a hysterectomy for example. Researchers know that microbeads can be used to starve benign and cancer tumors effectively. If the study I am enrolled in can provide data, along with further PAE research, to demonstrate the desired outcomes in BPH, it can serve as a reference to clinically study PAE to shrink cancer tumors in the prostate.

In fact, there are currently 35 prostate cancer PAE clinical trials underway all over the world. The results to date, seem to suggest similar outcomes compared to the standard of care. Researchers say it is promising, but more investigation needs to be done. Today, we do not seem to have a silver bullet for treating prostate cancer. A combination of monitoring, medication, procedures, hormone therapy, and radiation therapies are all used to suppress the disease. PAE could serve as a less-invasive alternative, in a phased approach on the way to definitive treatment options. What this could mean in the future is PAE will be another “tool” in the medical practitioner’s doctor bag.