Daniel R. Saltzstein, MD, describes steps Urology San Antonio has taken toward creation of a comprehensive urologic care practice, including establishment of a bone health clinic and an advanced prostate cancer clinic.
Daniel R. Saltzstein, MD
In a mission statement, the Large Urology Group Practice Association (LUGPA) states its aim to provide urological surgeons “…the means to access resources, technology and management tools… to care for patients with acute and chronic illnesses of the genitourinary system in an efficient, cost effective, and clinically superior manner.”
Urology San Antonio has transformed itself into a model reflective of these expanded group practice goals, part of a nascent trend in large urology group practices to provide cancer care where before patients would be referred out to oncologists. In this interview for Urologists in Cancer Care, Daniel R. Saltzstein, MD, director of Clinical Research, describes steps Urology San Antonio has taken toward creation of such a comprehensive urologic care practice, including establishment of a bone health clinic and an advanced prostate cancer clinic. Saltzstein looks ahead to new therapies that will continue to expand the options for advanced prostate cancer and the management of bone metastasis, and comments on the controversial recent US Preventive Services Task Force (USPSTF) statement on PSA screening.
Urologists in Cancer Care: Could you speak about your practice’s decision to start a bone health clinic? What provided the impetus, and what challenges did Urology San Antonio face in its early development? Dr Saltzstein: We realized a number of years ago, as more literature was being published, that androgen-deprivation therapy (ADT) was associated with a lot of potential side effects, and that as a specialty, we were not addressing those needs. It was difficult in our setting to change this. We had fragmented care. Among a group of 25 physicians, we had six offices and were addressing bone health and the various ADT side effects differently. As a group, we decided that we wanted to develop “centers of excellence” in standardized care. We thought it would be best if we managed this goal in one location, with a model that included “physician champions” and “physician extenders.” Within approximately one year we had instituted two clinics under the guise of our centers of excellence concept. One was a bone health clinic and one an advanced prostate cancer clinic.
How do you manage the delivery of the complex services you added to the practice with the launch of these clinics?
We manage with established protocols and the help of a physician assistant (PA). Each patient who comes to the clinic receives similar care. When a patient comes to the clinic for bone health issues arising from treatment with an androgen-deprivation therapy, we determine their status with DEXA scans. The PAs check compliance with calcium and vitamin D and exercise. Because androgen-deprivation therapy has side effects other than those relating to bone health, we check weight, cholesterol, diabetes status, and we inquire about symptoms such as hot flashes. If patients need a dental evaluation because we are worried about the side effects of some of the medicines, we take care of that.
The value of having a clinic like this is emphasized in light of new evidence for an improvement in survival with continuous androgen-deprivation therapy, meaning that patients may be taking it longer.1 This suggests that we will be dealing more and more with the side effects of these medicines.
Your large group practice also instituted an advanced prostate cancer clinic. Could you describe the rationale for that initiative?
We established an advanced prostate cancer clinic for reasons similar to those that resulted in the bone health clinic at Urology San Antonio—as a move toward a center of excellence concept, where all advanced prostate cancer care is provided in one setting.
Urologists now have a number of different products in our quiver (eg, sipuleucel-T, abiraterone, enzalutamide) that are “urology-friendly.” Urologists are very comfortable giving these medications in the office versus referring patients out to oncologists for advanced chemotherapeutic care.
Also, Urology San Antonio and a number of other large urology group practices throughout the country are starting to form alliances with oncologists to offer a “one-stop shopping” option for prostate cancer patients.
What involvement does your organization have in clinical trials, and how does your organizational structure support this activity along with rendering patient care?
We have an active clinical trials research division and have been involved in clinical trials for 12 to 15 years. Urology San Antonio Research, of which I am director, has been involved in clinical trials for many agents that have come out for the treatment of bone health and for advanced prostate cancer care.
We are currently involved in five to six prostate cancer trials for agents in different stages of development and also with studies of biomarkers which may complement PSA in the future. We are involved in a number of advanced prostate cancer trials, some of which involve the chemotherapeutic agent Taxotere. We are participating in early prostate cancer trials for patients who have failed early therapy, and we are also doing trials in prostate cancer pre-radical prostatectomy to see whether patients will respond to certain antioxidants.
Mutually beneficial alliances help to make possible the goal of Urology San Antonio to offer the full continuum of cancer care all in one setting and to participate in studies to advance treatment options. In one mutually beneficial alliance, an oncologist leases space in our radiation center, allowing us to give our patients chemotherapy. Patients with castrate-resistant prostate cancer who come into the office, for example, are managed by me and the physician extender. We make sure that each patient is given the opportunity to get involved in some of these new cancer treatments, whether or not they are on study.
Our radiation oncologist is a partner in Urology San Antonio. Physician extenders, who spend more time with patients, help to make sure that all “I’s” are dotted and “Ts” are crossed and that patients are compliant with vitamin D and calcium, and are working side-by-side successfully with the oncologists.
What trial results or new agents can you identify that may soon be an important part of the care of patients with urological cancer?
The biggest news in prostate cancer care is the recent FDA approval of enzalutamide, an oral androgen receptor inhibitor. Preliminary data in the post-chemotherapy space has shown an improvement of more than four months in survival with very little toxicity. It’s a drug that urologists are very familiar with because it is basically a sister drug to bicalutamide with a better survival profile. So this newly approved agent has a potentially huge impact on urologists’ practices.
The other one is abiraterone, which has been available for a while and is approved in chemotherapy failures, but is moving into the pre-chemotherapy space.
A new radiation product, radium-223, is a first alpha-pharmaceutical, with a short-range of penetration resulting in less penetration into the bone marrow, less bone marrow suppression, and better tolerance. A recently reported phase III study in patients with castrate-resistant prostate cancer and bone metastases showed a significant improvement in overall survival and a delay to time to first skeletal-related event, and less bone pain. This is a very exciting product still in clinical study.
Galeterone (TOK-001), an androgen biosynthesis inhibitor, received fast-track status by the FDA in June. This agent will compete with abiraterone. One of the challenges with abiraterone is that you need to give it with prednisone to prevent the side effects such as hypertension and fluid retention. Orteronel (TAK-700) is in a phase III clinical study in Japan. Because it is not necessary to give orteronel with prednisone, it will be more user-friendly for urologists who are not comfortable giving corticosteroids.
Do you have a sense, or have you assessed, whether patients like this new model of care?
For numerous reasons, patients like this model. Many of these patients have been receiving care under our auspices for 10 to 15 years, and over time they have developed close relationships with our staff. They may have had a radical prostatectomy, and it has failed. Maybe their PSAs are rising, and hormone therapy has failed. Patients may receive second-line hormone therapy, and now they are failing that. The model that we have created involves an enduring alliance between the urologist and a physician champion over the long term.
Patients feel almost abandoned if we send them off—refer them out.
Does the model you are describing—of providing care across the entire range of treatments and types of care for cancer and other patients for the long term, and in one physical setting—represent a national trend in urology group practices?
I think this kind of model is gaining momentum. I was just in Dallas with board members of LUGPA. There is a push by LUGPA to maintain the care of the prostate cancer patient within the urology clinic, and along with it a big push to educate urologists and LUGPA partners on how to implement this kind of model within their practices. Geographically it is a challenge, with different practice situations in different cities and locales. But it is starting to gain momentum. Whether the San Antonio model will be adopted by other large urology practices remains to be seen. This is a challenge, because every community has its own political, geographical, and logistical challenges.
Many professional and patient-interest and advocacy groups, including the American Urological Association, LUGPA, the American Association of Clinical Urologists, the Project to End Prostate Cancer (ZERO), the Men’s Health Network, and more, have issued strongly worded releases rejecting the recent USPSTF’s “D” recommendation against PSA screening. How would you comment on this action and the way in which it may affect decisions urologists make with their patients?
In a general sense, urologists are very upset, perhaps in the way gynecologists and oncologists were upset when the Task Force came out with the statement regarding no routine mammograms for women between the ages of 40 and 49 years. We understand, from a societal point of view, the cost issue: that the cost of curing one patient is too expensive, and that you have to screen 100 patients for one cure. It’s a dollar-and-cents issue in a country that is bankrupt and trying to allocate scarce healthcare dollars.
What bothers urologists is that there has been anywhere from a 40% to 45% improvement in prostate cancer-related survival in the PSA era. We get the fact that you have to screen 100 men to benefit seven men. Who is going to bear the cost of the other 93? But how can we discard the PSA test when we don’t have something to replace it, knowing that it has truly revolutionized prostate cancer care?
What the Task Force was saying is that: (1) we overdiagnose prostate cancer, and (2) we overtreat it, and that this is misusing the PSA and potentially causing a lot of morbidity in a lot of people who do not need to be exposed to morbidity.
The urologists’ comeback to that argument would be that we are told that the national average of positive prostate biopsies is probably about 25% to 28%. At Urology San Antonio, the prostate biopsy-positive rate, which is based on 1700 biopsies per year, is around 48%. So, according to their records we are under-biopsying people.
The other argument urologists make is that we are very good stewards of prostate cancer care. We are not overtreating prostate cancer. When we tracked our treatment paradigms in San Antonio we found that 30% of patients get surgery, 30% get radiation, 30% get some form of active surveillance, and maybe 10% get some form of hormone therapy. A 72-year-old man who is not very healthy, with a PSA of 8 and a positive biopsy, may go on to active surveillance and not suffer the potential morbidities of treatment. But a 68-year-old man with bad prostate cancer and a PSA of 4 and a Gleason score of 7-8 needs therapy. We know which men need therapy and which ones don’t.
The thought process of urologists is that until we have a better test than the PSA, appropriate men need to be screened. Trust us to make the right decisions for patients. In time, as newer molecular tests are developed, patients and urologists will be better able to select appropriate prostate cancer therapies.
1. Hussain M, Tangen CM, Higano CS, et al. Intermittent versus continuous androgen deprivation in hormone sensitive metastatic prostate cancer patients: results of S9346 (INT-0162), an international phase III trial. J Clin Oncol. 2012;30(suppl; abstr 4).