In this practice profile, David Albala, MD, sits down with urologist Christopher M. Pieczonka, MD, and radiation oncologist Neil F. Mariados, MD, to discuss the development of an advanced prostate cancer clinic.

Dr. Albala: Today, I am joined by Dr. Christopher Pieczonka and Dr. Neil Mariados of Associated Medical Professionals in Syracuse, NY, to gain insight into the development of an advanced prostate cancer clinic and what is needed to develop this program with advanced therapeutics using drugs such as radium Ra 223 dichloride, enzalutamide, and abiraterone acetate. Welcome, gentlemen—it is a pleasure to speak with you.

Dr. Mariados, you are a radiation oncologist. Can you give us some background on your training and on how you became interested in the area of advanced prostate cancer?

Dr. Mariados: Dave, thank you very much for this opportunity. It is a pleasure to talk about this subject. I am a radiation oncologist, had radiation oncology training, and after that did advanced training in brachytherapy and stereotactic radiosurgery. I became interested in all aspects of prostate cancer care, from patients who were diagnosed with early disease to those with more advanced disease. Over the years, I’ve started seeing more patients with advanced disease who also present with pain. Today we have more treatment options to offer our patients than we did when I completed my training.

Dr. Albala: Dr. Pieczonka, welcome. You are one of the key drivers for the development of an advanced prostate cancer treatment clinic. Please share with us your background in urology—where you did your training—and then I would like to ask you some in-depth questions about how you became interested in this area of advanced prostate cancer. After that, we will talk about how you set up the advanced prostate cancer program for your practice.

Dr. Pieczonka: Thank you, Dave. I did my training in the State University of New York at Buffalo and completed my residency in 2003; like many other young urologists, I wanted to join a group practice. I joined a practice of four other individuals years ago. My group evolved and took on other partners, and, over the past 13 years, our practice has grown to a group of roughly 25 urologists. I had access to many patients during my residency, both at the VA Hospital and at Roswell Park Cancer Institute (Buffalo, NY), and I saw quite a bit of advanced prostate cancer.

Dr. Albala: Dr. Mariados, could you tell us how things have changed over the past 5 to 10 years in radiation oncology? Has there been an upswing in the treatment of prostate cancer with radiation? Has there been a decrease?

Dr. Mariados: Active surveillance definitively decreased the number of patients receiving radiation. Now we are seeing an increase in patients with high-or intermediate-risk features. Prostate cancer treatments have changed markedly in the past 5 or 6 years based on new oral oncolytic agents and radium Ra 223 dichloride. Radium Ra 223 dichloride is the first radiopharmaceutical that has been shown to improve survival, which has been a game changer. We now have to educate our physician partners that radium Ra 223 dichloride is not an end-stage therapy. It is a therapy that can be introduced early on in the castrate-resistant patient population.

Dr. Albala: Dr. Pieczonka, how did you become interested in the development of an advanced prostate cancer clinic? Our audience members belong to both large and small groups. I know that you have had a large experience with drugs such as sipuleucel-T, enzalutamide, abiraterone acetate, and radium Ra 223 dichloride. How would one start a program like the one you have developed in Syracuse, and is it feasible for smaller groups to develop these kinds of programs?

Dr. Pieczonka: We started treating patients with advanced prostate cancer because when we did not, they went to oncologists to receive care. What sparked my interest was the ability to take care of these patients from “cradle to grave,” which is very similar to what gynecologic oncologists do with their patients. When these agents came to the market—which are all very urology-friendly medicines—it was easy to transition to doing something that is good and safe for patients that does not really put either individual clinicians or the group at significant risk. We started this process years ago, when sipuleucel-T came out. Sipuleucel-T was very conceptually interesting to me; knowing a little bit about immunology allowed me to explain it to my patients and I quickly found that the medicine was safe and easy to use. This paved the way for me to start using the oral oncolytic agents. When abiraterone came to market, I was originally very concerned about the need for blood work monitoring and the use of prednisone. As I’ve learned more about it over the years, I find it is a very safe medicine and very easily utilized. The same can be said for enzalutamide. The reason for setting these clinics up is to take care of patients who have been members of the practice for perhaps decades. Some of these patients may have had surgery 10 or 20 years ago, and we have an allegiance to them to be able to take care of them until their disease progresses to the point that they need further subspecialty therapy.

Dr. Albala: Dr. Pieczonka, do you think that smaller groups around the country can develop these advanced prostate cancer treatment programs, or is this something that is reserved for the larger groups? Obviously, you started using sipuleucel-T early on and have had success with that. Do you think that a two- or three-person group can provide these kinds of services? Obviously, you need to be familiar with the oral agents. It is interesting that you never received any advanced prostate cancer training. So, my questions to you are, can you develop these programs in smaller groups, and, how do you go about learning about these drugs to be able to dispense them in a proper fashion?

Dr. Pieczonka: I think it is interesting when you compare the surgical field to the medical field of urology; I would argue that small group practices of two or three people probably still do cystectomies, and they may only do two or three a year. The number of advanced prostate cancer patients an average small practice has is 10 times that number. Clearly, the volume is there; the first step is to learn to be comfortable with these types of patients. The easiest way to do this is through the American Urological Association, which sponsors multiple advanced prostate cancer courses. They are available at the national meeting, and there are regional standalone meetings throughout the year. LUGPA has also set up regional meetings to help develop these types of programs. In our practice, we had a physician, nurse, and administration champion the program. Once this has been established, it is easy to make the program successful. I perceive a dichotomy between the academic urologists and the nonacademic urologists, which I find frustrating. The nonacademic urologists are leading the fight to keep these prostate cancer patients in the urology offices, and I do not see the same thing happening in the academic urology offices, where many of the patients are seen by medical oncology and not referred back to urology. I would like to see residents who are now in training spend time with clinicians who have access to these patients.

Dr. Mariados: Chris, you touch on a very important point. Education of our partners and all treating physicians is critical to developing a successful program. The agents used in advanced prostate cancer have changed the way we need to think of these patients. Many of the data on these agents have suggested that, if given early in the disease course, significant improvements in quality of life and survival can be achieved.

Dr. Albala: Can you give us some direction on how you go about starting an advanced prostate cancer clinic?

Dr. Pieczonka: Our program was first developed by integrating sipuleucel-T therapy for our patients with asymptomatic or minimally symptomatic disease. This drug, which involves three cycles of leukapheresis and infusions, can be given in any office setting. Infusing these patients is an easy process, and the survival advantage is roughly 4 months when compared with placebo. We have found few significant side effects with this therapy. At the initial consult, I lay out the game plan for medical therapy. I also work closely with a radiation oncologist and we share many of these patients—in some ways we both are physician champions. We see more of these castrate-resistant patients today.

Dr. Albala: You bring up a good point about castrate-resistant patients. How difficult is it to set up a laboratory and what lessons have you learned?

Dr. Mariados: We were one of the early adopters of radium Ra 223 dichloride treatment, and we have done approximately 75 patient treatments to-date (nearly 400 infusions). I’ve had good outcomes in many of these patients, and we realize that we need to use it in the appropriate patient. To start the laboratory, the “hot lab” as we call it, we required a few pieces of equipment, which most medical physicists can put together in a radiation oncology office or in a urology office. We need the dose calibrator and appropriate shielding. We also need a Geiger counter; that is about it. The most important things that we need are special policies and procedures in place so that we comply with state regulations in case of an inspection. This is not very difficult. We have to have the appropriate people in place, and we need a licensed, authorized user. It is not difficult to get a license and the initial investment is approximately $5000 to $8000. One way to decrease this cost is to purchase used equipment. One infusion a week or four infusions a month is sufficient to support this type of program.

Dr. Albala: We heard Dr. Mariados talk about using radium Ra 223 dichloride and how radium Ra 223 dichloride has been added to our armamentarium. From a urologist’s perspective, how often do you prescribe this drug? Could you give us some tips on how you and Dr. Mariados set up the radium Ra 223 dichloride program in this practice?

Dr. Pieczonka: Radium Ra 223 dichloride is a spectacular medicine in terms of improvement in overall survival. In standalone comparisons of radium Ra 223 dichloride compared with the oral oncolytics or sipuleucel-T, and looking at the hazard ratio or the risk reduction in death with the medicine, radium Ra 223 dichloride rates among the best. This was instrumental for their US Food and Drug Administration approval. I give you that background because I feel strongly that this drug should be administered as early as possible. I talk to patients with the intent of giving them a full six courses of therapy; as a result, I look for a reason to give patients radium Ra 223 dichloride rather than for a reason not to.

Dr. Albala: One last question before we wrap up. It hinges around the development of this program. Do you think that it has made patients more inclined to stay within the care of a urologist rather than going to a medical oncologist? I remember the days when patients with advanced prostate cancer, after failing hormonal therapy, were referred to oncologists for chemotherapy and docetaxel and other agents; now it appears that these patients can stay in our practice. Do you envision the day that we, as urologists, give chemotherapy to these patients with advanced prostate cancer?

Dr. Pieczonka: There is an initiative to let urologists consider giving chemotherapy, but politics may be preventing that from happening. There were recent data suggesting that patients who present with high-volume prostate cancer with newly diagnosed metastasis will benefit from chemotherapy. I try to identify these patients early in their disease course. If they have a lot of metastasis and a prostate-specific antigen level 1000 ng/mL, for example, and they need chemotherapy, I tell the patients I will still captain the ship. I review the notes from their oncologists and inform them that they require a short period of chemotherapy. They receive six cycles of chemotherapy, as was shown in the ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) study, and then they come back and we treat them with radium Ra 223 dichloride or medicines. My biggest criticism is that once patients get started on chemotherapy the medical oncologist frequently will not make an attempt to take them off chemotherapy and switch them onto some other agent, and in particular I think there are many patients who would otherwise benefit from being on radium Ra 223 dichloride or oral agents.

Dr. Albala: Thank you very much for your insights on how to develop an advanced prostate cancer program. You are incredibly successful and provide a necessary service to these patients with castrate-resistant prostate cancer. Thank you for taking the time to talk.

Dr. Mariados: Thank you.

Dr. Pieczonka: Thank you. 

This transcript has been edited for style and clarity.