Lancaster Urology Brings Clinical Trials to Community Setting

Paul Sieber, MD

For many patients with advanced prostate cancer, especially those who live in rural areas, access to cutting-edge clinical trials is a hardship from a travel and financial perspective. Clinical trials are often conducted at large, academic medical centers, and the demanding regimen that accompanies trials can place patients and caregivers in a difficult situation.

Clinical Trials

Lancaster Urology, one of the largest—if not the largest—urology practice in western Pennsylvania, fills the geographic void between Pittsburgh and Philadelphia by providing the whole spectrum of urologic care. From genomic testing and diagnosis, to partial nephrectomies and prostatectomies, to drug regimens and clinical trials, Lancaster Urology has been serving the needs of this population since the 1960s.Lancaster Urology is committed to furthering research and providing the latest care to its patients through a wide variety of clinical trials. “The unique things we’ve offered in the cancer space is not so much new techniques, but with new drugs that aren’t on the market that people are looking for,” says Paul Sieber, MD, FACS, Lancaster Urology’s medical director for research and laboratory. Instead of traveling a great distance and spending more time than they would like seeking treatment, patients can come to Lancaster Urology for the same care. He also sees patients who research clinical trials online, and who are looking “particularly for M0 trials for prostate cancer, which involves patients with rising PSAs and difficult to find metastases. In the past, we’ve also done some renal cancer studies, some trials for people who have peroneus issues, and we did the original Botox trials.”

The group is conducting a study called EMBARK, a trial for people who have not received prior hormone therapy, but have rapidly rising PSAs and no metastases. The study is looking at a standard androgen-deprivation therapy (ADT) versus leuprolide (Lupron) in combination with enzalutamide (NCT02319837). “I think that has some intrigue, in that I wonder whether hitting patients harder [in the beginning of their treatment] would make a difference,” Sieber says.

Patients’ Financial Challenges

Other studies Sieber finds interesting are the M0 studies they are conducting, with 3 ongoing (2 closed and 1 still enrolling) for patients who are hormone-treatment naïve, but have rapidly rising PSAs and no metastases. Again, the point of interest is whether early, aggressive interventions make a difference in overall and progression-free survival.Patients are often incentivized to enroll in clinical trials when they run into financial diffculties with their treatments because their participation grants them access to free drugs. The Affordable Care Act (ACA), Sieber comments, drives many of the patients he sees to high-deductible insurance plans, with the notion that they are going to set up a Health Savings Account to cover the difference, although the amount set aside in savings is not often enough. This leads to many of his patients being unable to afford their ADT, or worse yet, “the cost to start the advanced therapeutics like sipuleucel-T (Provenge) or some of the newer, oral agents which leads to big out-of-pocket expenses they have to cover in terms of their pharmacy deductibles, and patients can’t cover it,” says Sieber.

Sieber also explains that while there is a push to have the drug companies lower their prices, however much they lower them, the drugs are still unaffordable for the average patient. Lancaster Urology sees many elderly patients on retirement pensions, and this presents a financial challenge many patients cannot overcome. Sieber sees some patients who delay starting treatment, due to having to schedule their co-payments strategically in order to make their medical bills’ ends meet. “So they’re not getting advanced care for their prostate cancer because they can’t afford it,” Sieber says. “That’s the big hurdle I see: patients not getting the treatment because they can’t afford it, and I don’t know how to get it for them.”

Hurdles for Independent Practices

Therefore, patients are often happy to be able to enroll in one of the many clinical trials Lancaster Urology offers. Sieber stresses that the problem is not on his practice’s end, but rather with the prices of many drugs, and he certainly does not want to “dangle financial incentives” in front of his patients. The best he and his colleagues can offer, at least for the time being, is a stellar clinical trial program.Another ongoing challenge for Lancaster Urology is maintaining their independence as a practice while competing with hospitals in the area. “We’re seeing that as [other] groups dwindle in size, they’re having even more trouble with recruiting,” Sieber says, and these practitioners are running into issues when they leave their practice.

The number of urologists in the area has started to dwindle, and Sieber thinks the solo practices are not going to merge, but instead are going to hand over their practices, “and that’s going to be a logistical problem for all of us because we don’t want to spend the day driving an hour or an hour and a half to a satellite clinic. And how do we manage those patients in an emergency? We’re not going to cover the local emergency rooms, so we would have to send our patients out, and I think that’s going to be the case for more of our patients,” Sieber explains.

This presents an issue in terms of hospitals hiring urologists, as well. There are issues with recruiting new doctors to smaller practices because the hospitals are enthusiastic to employ them first. “Everyone in my group is continuously getting headhunter ads in e-mails, all the time,” Sieber comments. This breeds a sort of animosity toward hospitals, since they offer large salaries initially, which attracts a lot of younger practitioners. Then after a few years of high pay, the hospitals may change the salary to reflect only as much as those practitioners are bringing in.

Especially in the Lancaster area, a new doctor recruited in this fashion will pay a price in a lack of work/life balance. “You’re always on call,” according to Sieber. In a private practice, Sieber says, you have more control of these factors, whereas in a hospital, it functions more like a corporation. “We’re already seeing that the hospitals have already bought up other practices, so there’s a lot of doctors leaving [hospitals in the area] this year. A number of employed physicians by the hospital have quit this year,” Sieber reports.

The goal, not only for Lancaster Urology but for other independent urology practices, is to learn how to thrive in an environment where the hospitals are competing against them. The largest hospital near Lancaster Urology was recently bought out by the Penn Medicine Health System, and Sieber, and his colleagues, wonder how this will affect their practice.

History and Location

Sieber predicts that, in the future, smaller hospitals are going to disappear, become part of larger systems, and control costs by controlling the practitioners who work for them. “Urology is unique in that, since our numbers are shrinking, it’s hard to squeeze urologists because they’re hard to find,” Sieber notes. He recommends merging with larger independent groups in order to maintain independence and negotiating power in the market. He also notes that there is a general push for specialization, which keeps individual doctors, and by extension their practices, in demand and different from larger hospitals. “You’re going to have to think about yourself, and what special talent you bring to the table that makes you valuable,” Sieber says.Lancaster Urology was not always a single group practice. Initially, there were 2 groups, and when the founding urologists came to Lancaster in the 1960s, they established a network of 7 groups. Those 7 groups then lessened to 5 over time, as the groups started to consolidate. In 2012, they merged into a single group, with 3 offices located in Lancaster, Lebanon, and Ephrata, Pennsylvania. The majority of their business is conducted at their main Lancaster office. The group is now comprised of 12 urologists, a part-time pathologist, a part-time radiation oncologist, and 2 nurse practitioners.

According to Sieber, they do occasionally have to send patients to another center, for complex cases that need more specialty treatments, like highly complex pediatric cases, testicular cancer patients, or a renal case where the patient requires major reconstructive surgery for a partial nephrectomy.

Patient Demographics

However, as Sieber comments, “There’s basically nothing between us and the Philadelphia area groups.” The urology group near Harrisburg is consolidated, and is roughly the size of Lancaster Urology, Sieber says. Other nearby urology practices are significantly smaller. With the next largest practices that offer clinical trials located in Ohio, the travel time for patients is often unreasonable. Lancaster Urology Group sees a number of patients who face this issue, and are glad for Lancaster Urology’s location providing an alternative to an academic center that may be out of reach.The patients who come to Lancaster Urology, Sieber reports, are unusual compared with other patient populations. Sieber and his colleagues see a higher-than-average Medicare population in their marketplace, as well as more elderly patients. “Lancaster County has become a retirement mecca, and particularly these retirement communities that o er condos, detached houses, or apartments with skilled care, are incredibly numerous here, about 21 different retirement communities,” Sieber says. According to Sieber, they are attracted to the area for a number of reasons, including cheaper housing, no state income tax on pensions, no tax on clothing, and little crime.

Sieber also notes that the Medicare population itself is somewhat different than others, in that the patients he sees tend to be more health conscious. He notices that the majority of his patients have often retired from New York and New Jersey, and because they are relatively more familiar with and close to larger urban areas, they tend to have a relatively progressive mindset about their healthcare. “Especially since we have these elderly patients,” Sieber says, “they don’t want to drive an hour and a half to Baltimore [for an academic treatment center], so if they can get treatment locally, that’s valuable.” “ADT Tuesday” A notable feature of the practice is their clinic for patients with metastatic prostate cancer, providing a variety of treatment options, including ADT. They run what Sieber and his colleagues call “ADT Tuesday.” Roughly 8 years ago, before the practice merged into one, the group purchased its own DEXA scanner, so that they could perform them in house. This led to their initial bone clinic for metastatic prostate cancer patients.

After the group started integrating the scans into their process, it became apparent to Sieber that there was insufficient follow-up for the patients who had abnormal scans, or for whom it was difficult to understand the risk of cancer. It was also clear that maintaining patients on ADT was becoming more difficult, since they had more patients on intermittent therapy. “With that in mind, and also to become more efficient in managing those patients, we morphed our bone clinic into an ADT clinic,” says Sieber.

At the time it was being set up, about 4 years ago, there was some hesitancy, according to Sieber. However, now it has become an integrated routine in Lancaster Urology; if a patient needs to start leuprolide acetate, they are sent to the ADT clinic.

Sieber goes on to explain that “ADT Tuesday” was created, in part, due to issues the practice ran into with insurance. He notes that, in the past, if a patient needed to start on Lupron, they would be able to administer the injection that day. However, prior authorization is now required, and that made it difficult to schedule treatments on Mondays. Thus, Tuesdays became the ideal day to run their ADT clinic. On Mondays, everything is lined up so the patients can receive their treatment in a timely and efficient manner.

Other Treatments Offered There

Recent Trends in Incidence

Having the treatment administered on a regular schedule has also made keeping track of patients easier, since everybody is scheduled promptly for their next visit. This is especially helpful, Sieber says, since ADT agents are all administered in 4-week, 12-week, 16-week, and 24-week cycles, making scheduling a challenge. Patients and their treating urologists will have vacations, conflicts, or life events that occur in those long spans of time, conflicting with their treatment regimen. Having a consistent scheduling day for ADT administration eliminates this conflict in Sieber’s practice.As previously mentioned, Sieber and his colleagues offer a wide array of options for their patients. They perform robotic-assisted prostatectomies, prostate cryotherapy, and modest amounts of brachytherapy, since many urologists no longer perform brachytherapy to treat patients with prostate cancer. For patients with kidney cancer, they routinely perform partial nephrectomies and renal cryotherapy. They also offer a variety of medications, like with their ADT clinic, to accommodate each patient’s needs.The patient volume for metastatic prostate cancer at Lancaster Urology is, as Sieber puts it, “booming.” He notes, in particular, that their use of Lupron and the enrollment in clinical trials studying prostate cancer is unusually high.

“I was talking to my billing manager, and she said, ‘I just can’t believe how many patients we’re giving Provenge, Lupron, and degarelix [Firmagon] to,’ and unfortunately the lack of screening is leading to, for us, robust numbers [of prostate cancer incidence],” Sieber says. The ICD-10-CM code for prostate cancer, C-61, has become the number 1 diagnostic code in their office.

Sieber goes on to explain that the focus on active surveillance falls at for his practice, since he sees a prevalence of aggressive cancer, and therefore, it is nearly impossible for him to see patients for active surveillance when they have metastatic disease. “The number of people that I’m managing now, who have metastatic disease, has just boomed, and others are seeing the same thing... The price we pay for not screening at all is that we’re going to have more people die from this disease,” Sieber comments.

Although he sees more patients with prostate cancer for treatment, these patients have failed on previous chemotherapies and sipuleucel-T, and this presents a greater challenge when trying to treat them. “I think we will see, as has been estimated before, that by 2020, our death rate will be back where it used to be [for prostate cancer],” Sieber notes.

Sieber also believes that diagnosing and treating prostate cancer is going to become more complex because of genomic profiling in high-risk patients. This will be especially challenging when coaching patients who have a family history of prostate cancer. “Now I’m starting to see patients who are BRCA positive, who don’t have prostate cancer yet, but what do we do with that information? I think the next big step is looking at genomics to understand patients’ risks, and I think that’s going to be part of the whole puzzle in the management of prostate cancer in terms of doing specific diagnostic tests,” Sieber says.