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.
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.
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’ Financial Challenges
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.”