Oncology Data Advisor: Welcome to Oncology Data Advisor. Today, I'm here with Dr. Christopher Iannuzzi, who is the Medical Director of Physician Services and the Chair of Oncology at Hartford HealthCare, St. Vincent's Medical Center. Dr. Iannuzzi is the Principal Investigator of an ongoing clinical trial for advanced prostate cancer at Hartford HealthCare, and today he's going to tell us some more about this trial, as well as some other advice for prostate cancer screening in light of Men's Health Month in November. Thank you so much for being here.

Christopher Iannuzzi, MD: Thank you for having me, I do appreciate it. We opened a trial, this is a national trial that's run through a number of major medical centers across the country, and we're proud to participate. I'm the local lead investigator, and this is a trial looking at high-risk prostate cancer patients.

When we think about prostate cancer, we try to categorize patients into what we call low, intermediate, or high risk, and based on that risk, it's determined how intense of a therapy is required for that patient. To fulfill the high-risk criteria, these are patients who either have very aggressive tumors—so they look angry under the microscope—or they have high prostate-specific antigens (PSAs), which are blood tests that can indicate prostate cancer. These patients have PSAs that are often greater than 20, or we have prostate cancer that's trying to creep out of the capsule. The standard of care for treatment of these patients in general is usually two years of hormonal therapy plus radiation.

Hormonal therapy is a bit of a misnomer in that we're actually not delivering hormones to a patient. We know that men have a natural hormone known as testosterone, and testosterone's actually the natural food supply for prostate cancer. In essence, what we do is we give the patient a pill and an injection, and that lowers their testosterone level and makes their body an infertile ground for prostate cancer. Then we combine that with a course of radiation therapy.

Where this trial comes in is that we know that these high-risk patients are a very heterogeneous group, which means that there are patients in this group that probably require less therapy, and there are patients in this group that probably require more therapy. As a way of personalized medicine or tailoring treatments, we want to try to come up with a way where we can really optimize the therapy for these patients, because lowering their testosterone level for that long has health implications.

The way that we try to tease this out is we use something called a genomic assay. What a genomic assay is, is it's looking at the biopsy specimens from the patient—the actual tumor—and they're looking at what we call cell cycle progression genes or genes that are involved in cancer growth. Based on the expression pattern of these genes, they can actually tell us if this appears to be a faster-growing tumor or a slower-growing tumor, and based on this genomic assay, patients are randomized to either less intensive therapy or more intensive therapy.

I think this is an important trial. I think it's in line with the notion that we are trying to optimize therapy for particular tumors and not just give one lump of patients all the same treatment. We are really excited to be a part of this trial.

Oncology Data Advisor: Great, thank you. It'll be exciting to hear about the results of the trial. Since you also do a lot of work in prostate stereotactic body radiation therapy (SBRT), would you like to tell us a little bit about this?

Dr. Iannuzzi: Yes, I would, very much so. That's referred to as stereotactic body radiation therapy. Just to back up a moment, the classic way of treating what we call localized prostate cancer—cancer that's really localized to the prostate gland—with radiation, was that a patient would have to come and visit us every day Monday through Friday for a total of nine weeks, so 45 visits. It's very effective treatment, but as you can imagine, it's fairly inconvenient.

What we've been working on over the last number of years as a specialty is the idea of trying to intensify the therapy and give it over a shorter period of time. So, take all that radiation over nine weeks and sort of consolidate it into a lesser time period. We first were able to do that over about five and a half weeks, and now we really can deliver all that radiation therapy in just five high-dose sessions.

What we've noted is that it's as effective, if not more effective, than the standard course of radiation therapy, and it's highly convenient in that it requires only six visits to a radiation center. One visit is for the planning, where we make a mold for the patient's body. We do a computed tomography (CT) scan and a magnetic resonance imaging (MRI) in that position. We use that information to plan out their treatment, and then just five sessions every other day in our radiation facility, and then the treatment is over. Patients tolerate this very well. Some people have some mild fatigue, some people have some irritation with urinary symptoms, and there can be some modest changes in sexual function.

One of the things that we do prior to delivering this kind of radiation is we ask the urologist to do two things. We ask them to put three markers in the prostate; we call them gold fiducial markers. They stay in the prostate forever. The patient never knows they're actually there, but I can see them on the television screen associated with our treatment machine. It allows me to make sure that the prostate's in the exact same position that it should be for each treatment.

Then we also place a strip of gel between the prostate and the rectum. Naturally, the prostate and the rectum are intimate structures, and we want to give high doses of radiation to the prostate, but we don't want to give high doses of radiation to the rectum, because that can cause some bleeding. That used to be a complication years ago that we would see quite often. What this gel does is it actually separates those two structures by a centimeter and allows us to deliver our treatment, and then that gel just sort of disappears over time. It creates a buffer zone for us, and it improves the safety of delivering this kind of radiation therapy.

At St. Vincent's Medical Center, we have a lot of experience with prostate SBRT. We find it to be highly successful and a real patient satisfier. I think it's just important for people to understand that we can deliver radiation like this now.

Oncology Data Advisor: That's great, thank you. Anything else you'd like to share about prostate cancer treatment, especially with it being Men's Health Month in November right now?