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Clinical Trial Tests Treatment for Enlarged Prostate

About 210 million men worldwide suffer from symptoms such as frequent or painful urination caused by an enlarged prostate, or benign prostatic hyperplasia (BPH).

A clinical trial at UVA is examining a non-surgical procedure for these symptoms called prostatic artery embolization.

Learn more about the trial from Ziv J. Haskal, MD, a UVA specialist in interventional radiology.

Clinical Trial Tests Treatment for Enlarged Prostate
Featured Speaker:
Ziv J Haskal, MD
Dr. Haskal is a tenured professor of radiology and medical imaging in the Division of Interventional Radiology at the University of Virginia School of Medicine. Dr. Haskal received his M.D. at Boston University School of Medicine and completed residency and fellowship at the University of California, San Francisco. As a sought after teacher and educator, Dr. Haskal has given more than 500 invited lectures worldwide and been awarded numerous honorary fellowships, national, international and societal awards for leadership, service and research excellence. He has designed, participated or led more than 40 research trials. Dr. Haskal has also published more than 400 scientific manuscripts, chapters, review, abstracts and editorials in journals ranging from Human Gene Therapy and the New England Journal of Medicine, to Circulation, JVIR, Radiology, Hepatology and more. The AHA Guidelines documented he co-chaired and co-wrote has received more than 2,700 citations.

Learn more about Dr. Haskal

Learn more about UVA Radiology and Medical Imaging 
Transcription:
Clinical Trial Tests Treatment for Enlarged Prostate

Melanie Cole (Host): About 210 million men worldwide suffer from symptoms such as frequent or painful urination caused by an enlarged prostate. A clinical trial at UVA is examining a non-surgical procedure for these symptoms called “prostatic artery embolization”. My guest today is Dr. Zeve Haskell; he's an interventional radiologist at UVA Health System. Welcome to the show, Dr. Haskell. First, let's talk about BPH or benign prostatic hyperplasia. What is that and how would a man know if they have it?

Dr. Zeve Haskell (Guest): Melanie, it's incredibly common in half of men aged between 51 and 60 and it increases to about 90% when they hit their 80s. Basically, the prostate is a big gland that sits under the bladder. As we get older, it grows, pushes up on the bladder, and it also squeezes the tube that carries urine outward--the urethra. So, we have symptoms that make it hard to initiate urination—can't start, and hard to empty the bladder, and in some cases, so bad that you're in the emergency room having a catheter placed.

Melanie: Wow. So, this is something that's so common and as we age as a society, you're seeing more and more men with it. What's the first line of defense when you notice someone has an enlarged prostate?

Dr. Haskell: Well, in 2010, we estimate that nearly $5 billion were spent on medications for this. So, the first line of therapy is tablets. Many men get some relief with these over several weeks or months. But, in those that fail, we start looking to more invasive options.

Melanie: So, tell us about some of those and then tell us about the clinical trial that you're doing for minimally-invasive options.

Dr. Haskell: Well, when the medications fail, folks will generally see a urologist who will discuss the various surgical options. In the rarest case, that will be a removal of the entire prostate. But, in most cases, it's something that's done through the urethra itself using a variety of things using lasers, or cutting tools, or even staplers, to push back the prostate or cut it out from the inside in order to make a larger passage. Those treatments are very effective but they do carry some real complications which are naturally a concern to all of us. Those include incontinence--being unable to hold urine; and sexual dysfunction as well--impotence or retrograde. That is reversed ejaculation. In looking for options that are less surgical or have less of these risks of these complications, we've sought, as interventional radiologists, to extend the types of things that we do for a living. We're choosing high-tech imaging to do minimally-invasive non-surgical treatments for almost everything in the body. And in the setting of the prostate, what we're essentially doing is injecting these tiny microscopic particles to reduce the blood supply to the prostate so it gradually shrinks in place.

Melanie: Wow. Now, this particular clinical trial is open so it's a national clinical trial, yes?

Dr. Haskell: Yes, that's right. It's a pilot study that is under the guidance of the FDA. We have it approved by the FDA, so we've chosen to do this rather than simply to offer the treatment to hold ourselves to the highest quality and rigor, to get the best evidence to support the widespread use of this in the US, and at the same time, provide the extremely detailed and high level of service and care when you're involved in a clinical investigation.

Melanie: So, as a potential alternative to other available and invasive surgical treatments, Dr. Haskell, tell us a little bit more about the PA procedure and what it involves.

Dr. Haskell: This was pioneered outside of the US and has been performed over a thousand times but the good, solid clinical information in the US is still lacking. As a patient, what it means is that you meet our team of urologists and interventional radiologists at our clinic. You get screened for the study, and if this is something that makes sense, then the actual procedure is done under light-conscious sedation. We have a tiny tube that is smaller than a spaghetti and more flexible than that. We pass that inside of the arteries and through that, an even tinier one directly to the ones of the prostate. We have some sophisticated imaging that allows us to make sure that we're only injecting this material into the prostate, not into adjacent things that we wouldn't want to block off. We do that to both sides and that usually takes us about an hour and a half. Patients are relaxed and awake and many of them are actually watching it on a black and white screen because you can't actually feel anything that is happening inside of the arteries. There are no nerves to feel with. We discharge our patients the next day and then we see them in follow up as part of our protocol which actually mimics what we'd want to do as best care, anyway.

Melanie: So, how long can they expect to see maybe some symptom relief if the prostate is shrinking from this procedure?

Dr. Haskell: Well, in some cases, men will experience some improvement within a week or two. More typically, it's gradual over several weeks and we have some patients who have had the same extraordinary good results that have been reported outside of the US and in other centers, as well, which is that those inability to hold urine or having to constantly go have really diminished or set the clock back many, many years, in that respect, without an operation.

Melanie: That's absolutely fascinating. What do you envision as the future of this procedure? Would it need to be redone, or is it something that's going to last 10 years as our population ages and men get older?

Dr. Haskell: Melanie, those are fabulous questions, and as a clinical researcher who's been working in this area of interventional radiology and embolization for 20 years, part of my job is to provide the best care but also to provide a beacon for the future of research and for centers elsewhere. So, we're looking to answer those very types of questions while giving our patients the best care. Will this last for 10 or 15 or 20 years? I don't know but we do this for patients with uterine fibroids and have for decades and we're able to repeat for women who grow new fibroids. So, it may be that the same options will be available for men, as well.

Melanie: How cool is that? And in just the last few minutes here, give your best advice for men suffering from BPH and where they can get more information about this clinical trial.

Dr. Haskell: Well, the first step is to make sure it is, indeed, the prostate and not the bladder which means being evaluated by a urologist and understanding what you have. We can certainly do that as part of our team approach at the clinic here in which we work in close partnership with our urologists. Everybody gets seen by everybody on the same day. If this is a good option that may spare you some of the surgical complications or you're looking to avoid being exposed to them, then you can reach us at 434-297-7136 or our email, which is uvaprostate@virginia.edu. That's 434-297-7136.

Melanie: The email is uvaprostate@virginia.edu. Thank you so much, Dr. Haskell, for being with us today. It's absolutely fascinating and we applaud all the great work that you're doing with this clinical trial. You're listening to UVA Health Systems Radio. And for more information, you can go to uvahealth.com. That's uvahealth.com. This is Melanie Cole. Thanks so much for listening.